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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Trunk Impairment Scale
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Trunk Impairment Scale
Time Frame: 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 Outcomes
- Forward Sitting Functional Reach Test(baseline, 6 weeks)
Investigators
Shamay Ng
Associate Professor
The Hong Kong Polytechnic University