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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
electrical stimulation with exercises
placebo stimulation with exercises
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Sitting balance, Stroke

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

electrical stimulation with exercises

placebo stimulation with exercises

Control

Arm Description

The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist.

The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 10, 2010
Last Updated
July 11, 2018
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01200030
Brief Title
Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Sitting balance, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrical stimulation with exercises
Arm Type
Experimental
Arm Description
The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist.
Arm Title
placebo stimulation with exercises
Arm Type
Placebo Comparator
Arm Description
The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
electrical stimulation with exercises
Intervention Description
electrical stimulation with exercises
Intervention Type
Behavioral
Intervention Name(s)
placebo stimulation with exercises
Intervention Description
placebo stimulation with exercises
Primary Outcome Measure Information:
Title
Trunk Impairment Scale
Description
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.
Time Frame
baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Forward Sitting Functional Reach Test
Description
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.
Time Frame
baseline, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamay Ng, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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