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Completed

NCT Number: NCT01200030

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrical stimulation with exercises

Behavioral

electrical stimulation with exercises

placebo stimulation with exercises

Behavioral

placebo stimulation with exercises

Primary outcomes

  1. 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

  1. Forward Sitting Functional Reach Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2010
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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