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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200030
• Other study ID #: DHSC_NG
• Secondary ID: DHSC_NG_001
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: December 31, 2014

Study information

• Verified date: July 2018
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 31, 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• electrical stimulation with exercises
electrical stimulation with exercises
• placebo stimulation with exercises
placebo stimulation with exercises

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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