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

NCT01200030 | Completed Results

• 2 other identifiers: DHSC_NGDHSC_NG_001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Sitting balance; Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 6 weeks

Secondary Outcomes (1)

• Forward Sitting Functional Reach Test

  baseline, 6 weeks

Study Arms (3)

electrical stimulation with exercises

EXPERIMENTAL

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

Behavioral: electrical stimulation with exercises

placebo stimulation with exercises

PLACEBO COMPARATOR

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

Behavioral: placebo stimulation with exercises

Control

NO INTERVENTION

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.

Interventions

electrical stimulation with exercises BEHAVIORAL

electrical stimulation with exercises

electrical stimulation with exercises

placebo stimulation with exercises BEHAVIORAL

placebo stimulation with exercises

placebo stimulation with exercises

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The number of home-visit in transcutaneous electrical stimulation (TES)+ task-related trunk training (TRlT) group and placebo-TES (pTES) + TRlT group was greater than the control group who had no active treatment.

Results Point of Contact

• Title: Dr. Shamay Ng
• Organization: The Hong Kong Polytechnic University

Shamay.Ng@polyu.edu.hk

(852) 2766-4889

Study Officials

• Shamay Ng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 31, 2014
• Last Updated: January 4, 2019
• Results First Posted: January 4, 2019

Record last verified: 2018-07

Locations

HK (1)