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SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to sensory impairments in stroke rehabilitation. The purpose of this trial is to investigate if sensory re-learning in combination with task-specific training may prove to be more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation, and life satisfaction. METHODS/DESIGN:This study is a single-blinded pilot randomized controlled trial (RCT) with two treatment arms. The participants will be randomly assigned either to sensory re-learning in combination with task-specific training (sensory group) or to task-specific training only (control group). The training will consist of 2.5 h of group training per session, 2 times per week for 5 weeks. The primary outcome measures to assess sensory function are as follows: Semmes-Weinstein monofilament, Shape/Texture Identification (STI™) test, Fugl-Meyer Assessment-upper extremity (FMA-UE; sensory section), and tactile object identification test. The secondary outcome measures to assess motor function are as follows: Box and Block Test (BBT), mini Sollerman Hand Function Test (mSHFT), Modified Motor Assessment Scale (M-MAS), and Grippit. To assess the ability to use the hand in daily activities, perceived participation, and life satisfaction, the Motor Activity Log (MAL), Canadian Occupational Performance Measure (COPM), Stroke Impact Scale (SIS) participation domain, and Life Satisfaction checklist will be used. Assessments will be performed pre- and post-training and at 3-month follow-up by independent assessors, who are blinded to the participants' group allocation. At the 3-month follow-up, the participants in the sensory group will also be interviewed about their general experience of the training and how effective they perceived the training. DISCUSSION:The results from this study can add new knowledge about the effectiveness of sensory re-learning in combination with task-specific training on UL functioning after stroke. If the new training approach proves efficient, the results can provide information on how to design a larger RCT in the future in persons with sensory impairments of the UL after stroke. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03336749 . Registered on 8 November 2017.

SUBMITTER: Carlsson H

PROVIDER: S-EPMC5904984 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial.

Carlsson Håkan H Rosén Birgitta B Pessah-Rasmussen Hélène H Björkman Anders A Brogårdh Christina C

Trials 20180417 1

<h4>Background</h4>Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to sensory impairments in stroke rehabilitation. The purpose of this trial is to investigate if sensory re-learning in combination with task-specific training may prove to be more effective than task-specific training alone to improve sensory function of the hand, dexterity, ...[more]

PMID: 29665842

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Project description:BackgroundSensorimotor impairments of the upper limb (UL) are common after stroke, but there is a lack of evidence-based interventions to improve functioning of UL.ObjectiveTo evaluate (1) the efficacy of sensory relearning and task-specific training compared to task-specific training only, and (2) the feasibility of the training in chronic stroke.DesignA pilot randomized controlled trial.SettingUniversity hospital outpatient clinic.ParticipantsTwenty-seven participants (median age; 62 years, 20 men) were randomized to an intervention group (IG; n = 15) or to a control group (CG; n = 12).InterventionBoth groups received training twice weekly in 2.5-hour sessions for 5 weeks. The training in the IG consisted of sensory relearning, task-specific training, and home training. The training in the CG consisted of task-specific training.Main outcome measuresPrimary outcome was sensory function (touch thresholds, touch discrimination, light touch, and proprioception). Secondary outcomes were dexterity, ability to use the hand in daily activities, and perceived participation. A blinded assessor conducted the assessments at baseline (T1), post intervention (T2), and at 3-month follow-up (T3). Nonparametric analyses and effect-size calculations (r) were performed. Feasibility was evaluated by a questionnaire.ResultsAfter the training, only touch thresholds improved significantly from T1 to T2 (p = .007, r = 0.61) in the IG compared to the CG. Within the IG, significant improvements were found from T1 to T2 regarding use of the hand in daily activities (p = .001, r = 0.96) and movement quality (p = .004, r = 0.85) and from T1 to T3 regarding satisfaction with performance in meaningful activities (p = .004, r = 0.94). The CG significantly improved the performance of using the hand in meaningful activities from T1 to T2 (p = .017, r = 0.86). The training was well tolerated by the participants and performed without any adverse events.ConclusionsCombined sensory relearning and task-specific training may be a promising and feasible intervention to improve UL sensorimotor function after stroke.

Project description:BackgroundIn the last few years, new noninvasive strategies have emerged as rehabilitative treatments for patients with stroke. Action observation treatment (AOT) is a rehabilitation approach based on the properties of the mirror neuron system with a positive impact on modifying cortical activation patterns and improving the upper limb kinematics. AOT involves the dynamic process of observing purposeful actions with the intention of imitating and then practicing those actions. In recent years, several clinical studies suggested the effectiveness of AOT in patients with stroke to improve motor recovery and autonomy in activities of daily living. However, a deeper knowledge of the behavior of the sensorimotor cortex during AOT seems to be essential.ObjectiveThe aim of this clinical trial, conducted in 2 neurorehabilitation centers and in patients' homes, is to investigate the effectiveness of AOT in patients with stroke, confirming the translational power of a tailored treatment. Particular emphasis will be placed on the predictive value of neurophysiological biomarkers. In addition, the feasibility and impact of a home-based AOT program will be investigated.MethodsA 3-arm, assessor-blinded, randomized controlled trial will be performed by enrolling patients with stroke in the chronic stage. A total of 60 participants will be randomly allocated to receive 15 sessions of AOT with different protocols (AOT at the hospital, AOT at home, and sham AOT), 3 sessions per week. The primary outcome will be assessed using the Fugl-Meyer Assessment-Upper Extremity scores. Secondary outcomes will be clinical, biomechanical, and neurophysiological assessment.ResultsThe study protocol is part of a project (project code GR-2016-02361678) approved and funded by the Italian Ministry of Health. The study began with the recruitment phase in January 2022, and enrollment was expected to end in October 2022. Recruitment is now closed (December 2022). The results of this study are expected to be published in spring 2023. Upon completion of the analyses, we will examine the preliminary effectiveness of the intervention and neurophysiological outcomes.ConclusionsThis study will be used to evaluate the effectiveness of 2 different AOT scenarios (ie, AOT at the hospital and AOT at home) in patients with chronic stroke and to assess the predictive value of neurophysiological biomarkers. Specifically, we will attempt to induce the functional modification of the cortical components by exploiting the features of the mirror neuron system, demonstrating relevant clinical, kinematic, and neurophysiological changes after AOT. With our study, we also want to provide, for the first time in Italy, the AOT home-based program while assessing its feasibility and impact.Trial registrationClinicalTrials.gov NCT04047134; https://clinicaltrials.gov/ct2/show/NCT04047134.International registered report identifier (irrid)DERR1-10.2196/42094.

Project description:Despite the functional impact of upper limb dysfunction in multiple sclerosis (MS), effects of intensive exercise programs and specifically robot-supported training have been rarely investigated in persons with advanced MS.To investigate the effects of additional robot-supported upper limb training in persons with MS compared to conventional treatment only.Seventeen persons with MS (pwMS) (median Expanded Disability Status Scale of 8, range 3.5-8.5) were included in a pilot RCT comparing the effects of additional robot-supported training to conventional treatment only. Additional training consisted of 3 weekly sessions of 30 min interacting with the HapticMaster robot within an individualised virtual learning environment (I-TRAVLE). Clinical measures at body function (Hand grip strength, Motricity Index, Fugl-Meyer) and activity (Action Research Arm test, Motor Activity Log) level were administered before and after an intervention period of 8 weeks. The intervention group were also evaluated on robot-mediated movement tasks in three dimensions, providing active range of motion, movement duration and speed and hand-path ratio as indication of movement efficiency in the spatial domain. Non-parametric statistics were applied.PwMS commented favourably on the robot-supported virtual learning environment and reported functional training effects in daily life. Movement tasks in three dimensions, measured with the robot, were performed in less time and for the transporting and reaching movement tasks more efficiently. There were however no significant changes for any clinical measure in neither intervention nor control group although observational analyses of the included cases indicated large improvements on the Fugl-Meyer in persons with more marked upper limb dysfunction.Robot-supported training lead to more efficient movement execution which was however, on group level, not reflected by significant changes on standard clinical tests. Persons with more marked upper limb dysfunction may benefit most from additional robot-supported training, but larger studies are needed.This trial is registered within the registry Clinical Trials GOV ( NCT02257606 ).

Project description:BackgroundTranscranial direct current stimulation (tDCS) and intermittent theta burst stimulation (iTBS) were both demonstrated to have therapeutic potentials to rapidly induce neuroplastic effects in various rehabilitation training regimens. Recently, we developed a novel transcranial electrostimulation device that can flexibly output an electrical current with combined tDCS and iTBS waveforms. However, limited studies have determined the therapeutic effects of this special waveform combination on clinical rehabilitation. Herein, we investigated brain stimulation effects of tDCS-iTBS on upper-limb motor function in chronic stroke patients.MethodsTwenty-four subjects with a chronic stroke were randomly assigned to a real non-invasive brain stimulation (NIBS; who received the real tDCS + iTBS output) group or a sham NIBS (who received sham tDCS + iTBS output) group. All subjects underwent 18 treatment sessions of 1 h of a conventional rehabilitation program (3 days a week for 6 weeks), where a 20-min NIBS intervention was simultaneously applied during conventional rehabilitation. Outcome measures were assessed before and immediately after the intervention period: Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Jebsen-Taylor Hand Function Test (JTT), and Finger-to-Nose Test (FNT).ResultsBoth groups showed improvements in FMA-UE, JTT, and FNT scores after the 6-week rehabilitation program. Notably, the real NIBS group had greater improvements in the JTT (p = 0. 016) and FNT (p = 0. 037) scores than the sham NIBS group, as determined by the Mann-Whitney rank-sum test.ConclusionsPatients who underwent the combined ipsilesional tDCS-iTBS stimulation with conventional rehabilitation exhibited greater impacts than did patients who underwent sham stimulation-conventional rehabilitation in statistically significant clinical responses of the total JTT time and FNT after the stroke. Preliminary results of upper-limb functional recovery suggest that tDCS-iTBS combined with a conventional rehabilitation intervention may be a promising strategy to enhance therapeutic benefits in future clinical settings.Trial registrationClinicalTrials.gov Identifier: NCT04369235. Registered on 30 April 2020.

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SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial.

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SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial.

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