Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke

Study Overview
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Brief Summary
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The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.

Detailed Description
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Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation. The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.

Official Title
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A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: electrical stimulation with exercises
* Behavioral: placebo stimulation with exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis with first stroke for more than 6 months Discharge from all rehabilitation services Ability to understand and follow commands A carer able for helping the home program No contraindication to assessment protocol and training Exclusion Criteria: Cognitive disorder with Abbreviated Mental Test less than 7 Unilateral neglect with Star cancellation Test less than 47 Sensory deficit Unable to give informed consent Unable to speak either Cantonese or English or Mandarin Commodity that preclude them from undergoing training and assessment Neurological disease other than stroke

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical stimulation with exercises<br>The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist. | Behavioral: electrical stimulation with exercises<br>* electrical stimulation with exercises<br>|
| Placebo Comparator: placebo stimulation with exercises<br>The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist. | Behavioral: placebo stimulation with exercises<br>* placebo stimulation with exercises<br>|
| No Intervention: Control<br>Subjects in this group did not receive any active training. Home safety advice and health education including diet control and blood pressure monitoring were given to the subjects during the home-visit and telephone follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk Impairment Scale | The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk. | baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forward Sitting Functional Reach Test | Sitting Functional Reach was used to assess the limits of stability in reaching activities. The sitting functional reach test measures how far forward, from a sitting position, a subject can bend forward to reach without losing his/her balance. A longer reaching distance indicated a better trunk control. | baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sitting balance, Stroke