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Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients.

ABSTRACT: Most acute stroke patients with disabilities do not receive recommended rehabilitation following discharge to the community. Functional and social barriers are common reasons for non-adherence to post-discharge rehabilitation. Home rehabilitation is an alternative to centre-based rehabilitation but is costlier. Tele-rehabilitation is a possible solution, allowing for remote supervision of rehabilitation and eliminating access barriers. The objective of the Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial is to determine if a novel tele-rehabilitation intervention for the first three months after stroke admission improves functional recovery compared to usual care.This is a single blind (evaluator blinded), parallel, two-arm randomised controlled trial study design involving 100 recent stroke patients. The inclusion criteria are age ?40 years, having caregiver support and recent stroke defined as stroke diagnosis within 4 weeks. Consenting participants will be randomized with varying block size of 4 or 6 assuming a 1:1 treatment allocation with the participating centre as the stratification factor. The baseline assessment will be done within 4 weeks of stroke onset, followed by follow-up assessments at 3 and 6 months. The tele-rehabilitation intervention lasts for 3 months and includes exercise 5-days-a-week using an iPad-based system that allows recording of daily exercise with video and sensor data and weekly video-conferencing with tele-therapists after data review. Those allocated to the control group will receive usual care. The primary outcome measure is improvement in life task's social activity participation at three months as measured by the disability component of the Jette Late Life Functional and Disability Instrument (LLFDI). Secondary outcome variables consist of gait speed (Timed 5-Meter Walk Test) and endurance (Two-Minute Walk test), performance of basic activities of daily living (Shah-modified Barthel Index), balance confidence (Activities-Specific Balance Confidence Scale), patient self-reported health-related quality-of-life [Euro-QOL (EQ-5D)], health service utilization (Singapore Stroke Study Health Service Utilization Form) and caregiver reported stress (Zarit Caregiver Burden Inventory).The goal of this trial is to provide evidence on the potential benefit and cost-effectiveness of this novel tele-rehabilitation programme which will guide health care decision-making and potentially improve performance of post-stroke community-based rehabilitation.This trial protocol was registered under ClinicalTrials.gov on 18 July 2013 as study title "The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study" (ID: The STARS Study, ClinicalTrials.gov Identifier: NCT01905917 ).

SUBMITTER: Koh GC

PROVIDER: S-EPMC4560876 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients.

Koh Gerald Choon-Huat GC Yen Shih Cheng SC Tay Arthur A Cheong Angela A Ng Yee Sien YS De Silva Deidre Anne DA Png Carolina C Caves Kevin K Koh Karen K Kumar Yogaprakash Y Phan Shi Wen SW Tai Bee Choo BC Chen Cynthia C Chew Effie E Chao Zhaojin Z Chua Chun En CE Koh Yen Sin YS Hoenig Helen H

BMC neurology 20150905

<h4>Background</h4>Most acute stroke patients with disabilities do not receive recommended rehabilitation following discharge to the community. Functional and social barriers are common reasons for non-adherence to post-discharge rehabilitation. Home rehabilitation is an alternative to centre-based rehabilitation but is costlier. Tele-rehabilitation is a possible solution, allowing for remote supervision of rehabilitation and eliminating access barriers. The objective of the Singapore Tele-techn ...[more]

PMID: 26341358

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Project description:BackgroundBreast cancer is the leading cancer affecting women in Singapore. Its survivors commonly experience decline in physical function and quality of life post-mastectomy, due to their upper limb morbidity and wound issues. Rehabilitation can address the aforementioned issues. When rehabilitation is accessible and easy to adhere, it can optimize recovery. Home-based tele-rehabilitation guided by healthcare professionals and self-managed by patients can potentially optimize the patients' adherence to rehabilitation and recovery. With that in mind, a team of breast cancer specialists (oncologists, nurses, and therapists) in Singapore has developed one of the first tele-rehabilitation systems for local women undergoing a unilateral mastectomy. To our knowledge, no such systems have been evaluated or proven effective as a treatment option among local breast cancer patients with acute disabilities.MethodsThis is a pilot quasi-experimental trial that aims to evaluate the feasibility of tele-rehabilitation and tele-drain care compared to usual care. Up to 40 patients (20 per group) will be recruited for this trial. They will be assigned to an intervention group that receives rehabilitation via a tele-rehabilitation system or a control group that receives rehabilitation in person at their clinic. The primary outcome of this trial is rehabilitation participation (i.e., the time spent on rehabilitation). The secondary outcomes are upper extremity functioning, perceived health, and quality of life.DiscussionAs part of this pilot trial, patients who opt in for the tele-rehabilitation will be asked to share their experience with and thoughts on the tele-rehabilitation system. With the evidence obtained from the tele-rehabilitation patients of this trial, we will be able to improve the current system for our future trial. Further, our additional data on rehabilitation participation, physical function, and quality of life will help us design a sufficiently powered future main trial.Trial registrationThe trial was approved by the National Healthcare Group's Domain Specific Review Board (#2019/00283) and registered with www.ClinicalTrials.gov (# NCT04269967 ) in February 2020.

Project description:BackgroundThe high incidence of cerebral apoplexy makes it one of the most important causes of adult disability. Gait disorder is one of the hallmark symptoms in the sequelae of cerebral apoplexy. The recovery of walking ability is critical for improving patients' quality of life. Innovative virtual reality technology has been widely used in post-stroke rehabilitation, whose effectiveness and safety have been widely verified. To date, however, there are few studies evaluating the effect of immersive virtual reality on stroke-related gait rehabilitation. This study outlines the application of immersive VR-assisted rehabilitation for gait rehabilitation of stroke patients for comparative evaluation with traditional rehabilitation.MethodsThe study describes a prospective, randomized controlled clinical trial. Thirty-six stroke patients will be screened and enrolled as subjects within 1 month of initial stroke and randomized into two groups. The VRT group (n?=?18) will receive VR-assisted training (30?min) 5?days/week for 3?weeks. The non-VRT group (n?=?18) will receive functional gait rehabilitation training (30?min) 5?days/week for 3?weeks. The primary outcomes and secondary outcomes will be conducted before intervention, 3?weeks after intervention, and 6?months after intervention. The primary outcomes will include time "up & go" test (TUGT). The secondary outcomes will include MMT muscle strength grading standard (MMT), Fugal-Meyer scale (FMA), motor function assessment scale (MAS), improved Barthel index scale (ADL), step with maximum knee angle, total support time, step frequency, step length, pace, and stride length.DiscussionVirtual reality is an innovative technology with broad applications, current and prospective. Immersive VR-assisted rehabilitation in patients with vivid treatment scenarios in the form of virtual games will stimulate patients' interest through active participation. The feedback of VR games can also provide patients with performance awareness and effect feedback, which could be incentivizing. This study may reveal an improved method of stroke rehabilitation which can be helpful for clinical decision-making and future practice.Trial registrationChinese Clinical Trial Registry ChiCTR1900025375 . Registered on 25 August 2019.

Project description:Background: Stroke is a leading cause of disability. Nonetheless, the care pathway for stroke rehabilitation takes partially into account the needs of chronic patients. This is due in part to the lack of evidence about the mechanisms of recovery after stroke, together with the poor knowledge of related and influencing factors. Here we report on the study protocol "Rehabilitation and Biomarkers of Stroke Recovery," which consists of 7 work-packages and mainly aim to investigate the effects of long-term neurorehabilitation on stroke patients and to define a related profile of (clinical-biological, imaging, neurophysiological, and genetic-molecular) biomarkers of long-term recovery after stroke. The work-package 1 will represent the main part of this protocol and aims to compare the long-term effects of intensive self-rehabilitation vs. usual (rehabilitation) care for stroke. Methods: We planned to include a total of 134 adult subacute stroke patients (no more than 3 months since onset) suffering from multidomain disability as a consequence of first-ever unilateral ischemic stroke. Eligible participants will be randomly assigned to one of the following groups: intensive self-rehabilitation (based on the principles of "Guided Self-Rehabilitation Contract") vs. usual care (routine practice). Treatment will last 1 year, and patients will be evaluated every 3 months according to their clinical presentation. The following outcomes will be considered in the main work-package: Fugl-Meyer assessment, Cognitive Oxford Screen Barthel Index, structural and functional neuroimaging, cortical excitability, and motor and somatosensory evoked potentials. Discussion: This trial will deal with the effects of an intensive self-management rehabilitation protocol and a related set of biomarkers. It will also investigate the role of training intensity on long-term recovery after stroke. In addition, it will define a set of biomarkers related to post-stroke recovery and neurorehabilitation outcome in order to detect patients with greater potential and define long-term individualized rehabilitation programs. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04323501.

Project description:BackgroundIn recent years, many studies focused on the use of robotic devices for both the assessment and the neuro-motor reeducation of upper limb in subjects after stroke, spinal cord injuries or affected by neurological disorders. Contrarily, it is still hard to find examples of robot-aided assessment and rehabilitation after traumatic injuries in the orthopedic field. However, those benefits related to the use of robotic devices are expected also in orthopedic functional reeducation.MethodsAfter a wrist injury occurred at their workplace, wrist functionality of twenty-three subjects was evaluated through a robot-based assessment and clinical measures (Patient Rated Wrist Evaluation, Jebsen-Taylor and Jamar Test), before and after a 3-week long rehabilitative treatment. Subjects were randomized in two groups: while the control group (n = 13) underwent a traditional rehabilitative protocol, the experimental group (n = 10) was treated replacing traditional exercises with robot-aided ones.ResultsFunctionality, assessed through the function subscale of PRWE scale, improved in both groups (experimental p = 0.016; control p < 0.001) and was comparable between groups, both pre (U = 45.5, p = 0.355) and post (U = 47, p = 0.597) treatment. Additionally, even though groups' performance during the robotic assessment was comparable before the treatment (U = 36, p = 0.077), after rehabilitation the experimental group presented better results than the control one (U = 26, p = 0.015).ConclusionsThis work can be considered a starting point for introducing the use of robotic devices in the orthopedic field. The robot-aided rehabilitative treatment was effective and comparable to the traditional one. Preserving efficacy and safety conditions, a systematic use of these devices could lead to decrease human therapists' effort, increase repeatability and accuracy of assessments, and promote subject's engagement and voluntary participation. Trial Registration ClinicalTrial.gov ID: NCT04739644. Registered on February 4, 2021-Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT04739644 .

Project description:Background: The reliable assessment, attribution, and alleviation of upper-limb joint stiffness are essential clinical objectives in the early rehabilitation from stroke and other neurological disorders, to prevent the progression of neuromuscular pathology and enable proactive physiotherapy toward functional recovery. However, the current clinical evaluation and treatment of this stiffness (and underlying muscle spasticity) are severely limited by their dependence on subjective evaluation and manual limb mobilization, thus rendering the evaluation imprecise and the treatment insufficiently tailored to the specific pathologies and residual capabilities of individual patients. Methods: To address these needs, the proposed clinical trial will employ the NEUROExos Elbow Module (NEEM), an active robotic exoskeleton, for the passive mobilization and active training of elbow flexion and extension in 60 sub-acute and chronic stroke patients with motor impairments (hemiparesis and/or spasticity) of the right arm. The study protocol is a randomized controlled trial consisting of a 4-week functional rehabilitation program, with both clinical and robotically instrumented assessments to be conducted at baseline and post-treatment. The primary outcome measures will be a set of standard clinical scales for upper limb spasticity and motor function assessment, including the Modified Ashworth Scale and Fugl-Meyer Index, to confirm the safety and evaluate the efficacy of robotic rehabilitation in reducing elbow stiffness and improving function. Secondary outcomes will include biomechanical, muscular activity, and motor performance parameters extracted from instrumented assessments using the NEEM along with synchronous EMG recordings. Conclusions: This randomized controlled trial aims to validate an innovative instrumented methodology for clinical spasticity assessment and functional rehabilitation, relying on the precision and accuracy of an elbow exoskeleton combined with EMG recordings and the expertise of a physiotherapist, thus complementing and maximizing the benefits of both practices. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04484571.

Project description:IntroductionMany patients with stroke have moderate to severe long-term sensorimotor impairments, often including inability to execute movements of the affected arm or hand. Limited recovery from stroke may be partly caused by imbalanced interaction between the cerebral hemispheres, with reduced excitability of the ipsilesional motor cortex while excitability of the contralesional motor cortex is increased. Non-invasive brain stimulation with inhibitory repetitive transcranial magnetic stimulation (rTMS) of the contralesional hemisphere may aid in relieving a post-stroke interhemispheric excitability imbalance, which could improve functional recovery. There are encouraging effects of theta burst stimulation (TBS), a form of TMS, in patients with chronic stroke, but evidence on efficacy and long-term effects on arm function of contralesional TBS in patients with subacute hemiparetic stroke is lacking.Methods and analysisIn a randomised clinical trial, we will assign 60 patients with a first-ever ischaemic stroke in the previous 7-14 days and a persistent paresis of one arm to 10 sessions of real stimulation with TBS of the contralesional primary motor cortex or to sham stimulation over a period of 2?weeks. Both types of stimulation will be followed by upper limb training. A subset of patients will undergo five MRI sessions to assess post-stroke brain reorganisation. The primary outcome measure will be the upper limb function score, assessed from grasp, grip, pinch and gross movements in the action research arm test, measured at 3?months after stroke. Patients will be blinded to treatment allocation. The primary outcome at 3?months will also be assessed in a blinded fashion.Ethics and disseminationThe study has been approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, The Netherlands. The results will be disseminated through (open access) peer-reviewed publications, networks of scientists, professionals and the public, and presented at conferences.Trial registration numberNTR6133.

Project description:BackgroundMost surviving hip-fracture patients experience reduced mobility and lose some of their functional ability, which increases the risk of complications and rehospitalization. Post-discharge transitional programs to reduce readmissions and disabilities have shown some success. Telerehabilitation refers to the use of technologies to provide rehabilitation services to people in their homes. Considering the need for long-term follow-up care for people with hip fracture, in-home telerehabilitation could increase independence, decrease hospital stays and reduce the burden for caregivers. The objective of this study is to investigate the effectiveness of an intervention program based on telerehabilitation on activities of daily living (ADL), quality of life (QOL), depression and burden on caregivers compared to face-to-face home visits and usual care of community-dwelling older adults after hip fracture.Methods/designThis will be a three-armed randomized control trial (RCT) including pre/post intervention and follow-up. The trial will include 90 older people with hip fractures who will be randomly assigned to a telerehabilitation group (N = 30), face-to-face visits (N = 30) and a control group. The aim of the intervention is to improve the transition from rehabilitation units to community dwelling. It will include 10 videoconferencing/ face-to-face sessions from an occupational therapist in the presence of the primary caregiver. Each session will be utilized to guide the participants to achieve their self-identified goals, focusing on problem-solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities. Outcome measures include Functional Independence Measure (FIM) for evaluation of ADL, SF-12 for evaluation of Health-related QOL, The Geriatric Depression Scale (GDS) and The Zarit Caregiver Burden Scale. Data will be analyzed using Repeated measures MANOVA.DiscussionThe current study will enable the cost-effectiveness examination of a suggested rehabilitation service based on available technology. The proposed intervention will increase accessibility of in-home rehabilitation services, improve function and health, and reduce economic burden.Trial registrationNCT03376750 (12/15/2017).

Dataset Information

Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients.

Publications

Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients.

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