Dataset Information

Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial.

ABSTRACT:

Background

This feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.

Methods/design

This is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.

Discussion

This study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.

Trial registration isrctn

ISRCTN56716589.

SUBMITTER: Turton AJ

PROVIDER: S-EPMC3675391 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial.

Turton Ailie J AJ Cunningham Paul P Heron Emma E van Wijck Frederike F Sackley Cath C Rogers Chris C Wheatley Keith K Jowett Sue S Wolf Steven L SL van Vliet Paulette P

Trials 20130425

<h4>Background</h4>This feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.<h4>Methods/design</h4>This is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to ...[more]

PMID: 23782653

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Project description:BACKGROUND:Post-stroke physical inactivity is explained by several factors related to the stroke, which have been suggested as the causes and consequences of functional declines and health problems. Therefore, it is important to increase physical activity levels and reduce the time spent in low-energy expenditure activities after a stroke. Since the maintenance of cardiorespiratory fitness is a significant predictor of physical activity levels post-stroke, it may be important to investigate whether aerobic training is effective in increasing physical activity levels and reducing the time spent in low-energy expenditure activities in this population. The efficacy of aerobic training on these variables is not well known. The primary objective of this trial will be to investigate the effects of aerobic treadmill training on physical activity levels and on time spent in low-energy expenditure activities in people with stroke. The secondary aim will be to evaluate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation. METHODS/DESIGN:A randomized controlled trial, with blinded assessments, will be performed in a community-based setting. Altogether, 22 adults with a diagnosis of stroke (>6 months) who are sedentary or insufficiently active will be included. Participants will be randomly assigned to either: (1) aerobic treadmill training (experimental group, at 60-80% of their heart rate reserve) or (2) walking outside (control group, below 40% of heart rate reserve). Both groups will attend 40-min training sessions, three times per week over 12 weeks, in groups of two to four participants, with a trained physiotherapist. Primary outcomes are physical activity levels and time spent in low-energy expenditure activities (Multi-sensor SenseWear Mini® and Human Activity Profile). Secondary outcomes are cardiorespiratory fitness (peak oxygen uptake VO2peak and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the training will be analyzed from the collected data using intention to treat. Between-group differences will be measured by two-way repeated measures ANOVA, considering the baseline, post-training, and 4-week follow-up. DISCUSSION:The results of this trial will likely provide valuable new information on the effects of aerobic treadmill training on physical activity levels and on time spent in low-energy expenditure activities of individuals with stroke, through changes in cardiorespiratory fitness. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02798237 . Registered on 13 June 2016.

Project description:BackgroundStroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.MethodsIn this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried.DiscussionThe final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment.Trial registrationClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.

Project description:BackgroundIn people with chronic obstructive pulmonary disease (COPD), limb-muscle dysfunction is one of the most troublesome systemic manifestations of the disease, which at the functional level is evidenced by reduced strength and endurance of limb muscles. Improving limb-muscle function is an important therapeutic goal of COPD management, for which resistance training is recommended. However, current guidelines for resistance training in COPD mainly focus on improving muscle strength which only reflects one aspect of limb-muscle function and does not address the issue of reduced muscle endurance. The latter is of importance considering that the reduction in limb-muscle endurance often is greater than that of muscle weakness, and also, limb-muscle endurance seems to be closer related to walking capacity as well as arm function than to limb-muscle strength within this group of people. Thus, strategies targeting multiple aspects of the decreased muscle function are warranted to increase the possibility for an optimal effect for the individual patient. Periodized resistance training, which represents a planned variation of resistance training variables (i.e., volume, intensity, frequency, etc.), is one strategy that could be used to target limb-muscle strength as well as limb-muscle endurance within the same exercise regimen.MethodsThis is an international, multicenter, randomized controlled trial comparing the effect and feasibility of non-linear periodized resistance training to traditional non-periodized resistance training in people with COPD. Primary outcomes are dynamic limb-muscle strength and endurance. Secondary outcomes include static limb-muscle strength and endurance, functional performance, quality of life, dyspnea, intramuscular adaptations as well as the proportion of responders. Feasibility of the training programs will be assessed and compared on attendance rate, duration, satisfaction, drop-outs as well as occurrence and severity of any adverse events.DiscussionThe proposed trial will provide new knowledge to this research area by investigating and comparing the feasibility and effects of non-linear periodized resistance training compared to traditional non-periodized resistance training. If the former strategy produces larger physiological adaptations than non-periodized resistance training, this project may influence the prescription of resistance training in people with COPD.Trial registrationClinicalTrials.gov, ID: NCT03518723 . Registered on 13 April 2018.

Project description:BACKGROUND:Virtual reality training (VRT) uses computer software to track a user's movements and allow him or her to interact with a game presented on a television screen. VRT is increasingly being used for the rehabilitation of arm function, balance and walking after stroke. Patients often require ongoing therapy post discharge from inpatient rehabilitation. Outpatient therapy may be limited or inaccessible due to waiting lists, transportation issues, distance etc.; therefore, home-based VRT could provide the required therapy in a more convenient and accessible setting. The objectives of this parallel randomized feasibility trial are to determine (1) the feasibility of using VRT in the home post stroke and (2) the feasibility of a battery of quantitative and qualitative outcome measures of stroke recovery. METHODS:Forty patients who can stand for at least 2 min and are soon to be discharged from inpatient or outpatient rehabilitation post stroke are being recruited in Ottawa, Canada and being randomized to control and experimental groups. Participants in the experimental group use home-based VRT to do rehabilitative exercises for standing balance, stepping, reaching, strengthening and gentle aerobic fitness. Control group participants use an iPad with apps selected to rehabilitate cognition, hand fine motor skills and visual tracking/scanning. Both groups are instructed to perform 30?min of exercise 5?days a week for 6?weeks. VRT intensity and difficulty are monitored and adjusted remotely. Weekly telephone contact is made with all participants. Ability to recruit participants, ability to handle the technology and learn the activities, compliance, safety, enjoyment, perceived efficacy and cost of program delivery will be assessed. A battery of assessments of standing balance, gait and community integration will be assessed for feasibility of completion within this population and potential for improvement following the intervention. Effect sizes will be calculated. DISCUSSION:The results of this study will be used to support the creation of a definitive randomized controlled trial on the efficacy of home-based VRT for rehabilitation post stroke. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03261713 . Registered on 21 August 2017. Registration amended on 1 June 2018 to decrease enrollment from 40 to 20 due to a cut in study funding and difficulty recruiting participants.

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Dataset Information

Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial.

Background

Methods/design

Discussion

Trial registration isrctn

Publications

Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial.

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