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

T

The Hong Kong Polytechnic University

Status

Completed

Conditions

Stroke

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01200030
DHSC_NG_001
DHSC_NG

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

37 participants in 3 patient groups, including a placebo group

electrical stimulation with exercises
Experimental group
Description:
The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist.
Treatment:
Behavioral: electrical stimulation with exercises
placebo stimulation with exercises
Placebo Comparator group
Description:
The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist.
Treatment:
Behavioral: placebo stimulation with exercises
Control
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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