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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: electrical stimulation with exercises; Behavioral: placebo stimulation with exercises

• Registration Number: NCT01200030
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Primary Completion: 2014-12
• Study Completion: 2014-12-31
• Results First Submitted: 2017-08-14
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-11
• Last Update Submitted: 2018-07-11
• Results First Posted: 2019-01-04
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Diagnosis with first stroke for more than 6 months
2. Discharge from all rehabilitation services
3. Ability to understand and follow commands
4. A carer able for helping the home program
5. No contraindication to assessment protocol and training

Exclusion Criteria

1. Cognitive disorder with Abbreviated Mental Test less than 7
2. Unilateral neglect with Star cancellation Test less than 47
3. Sensory deficit
4. Unable to give informed consent
5. Unable to speak either Cantonese or English or Mandarin
6. Commodity that preclude them from undergoing training and assessment
7. Neurological disease other than stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electrical stimulation with exercises	electrical stimulation with exercises	The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist.
placebo stimulation with exercises	placebo stimulation with exercises	The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist.

Primary Outcome Measures

Name	Time	Method
Trunk Impairment Scale	baseline, 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Forward Sitting Functional Reach Test	baseline, 6 weeks	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.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong