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

NCT ID: NCT01200030

Last Updated: 2019-01-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-12-31

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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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electrical stimulation with exercises

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

Group Type EXPERIMENTAL

electrical stimulation with exercises

Intervention Type BEHAVIORAL

electrical 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.

Group Type PLACEBO_COMPARATOR

placebo stimulation with exercises

Intervention Type BEHAVIORAL

placebo stimulation with exercises

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electrical stimulation with exercises

electrical stimulation with exercises

Intervention Type BEHAVIORAL

placebo stimulation with exercises

placebo stimulation with exercises

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Shamay Ng

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shamay Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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DHSC_NG_001

Identifier Type: -

Identifier Source: secondary_id

DHSC_NG

Identifier Type: -

Identifier Source: org_study_id

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