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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The Hong Kong Polytechnic University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01200030
First received: September 10, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Stroke
Behavioral: electrical stimulation with exercises
Behavioral: placebo stimulation with exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Trunk impairments [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Scoring with trunk imapirment scale


Secondary Outcome Measures:
  • Sitting balance [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    measuring the distance of sitting functional reach test


Estimated Enrollment: 36
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: electrical stimulation with exercises Behavioral: electrical stimulation with exercises
electrical stimulation with exercises
Placebo Comparator: placebo stimulation with exercises Behavioral: placebo stimulation with exercises
placebo stimulation with exercises
No Intervention: Control

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200030

Contacts
Contact: Shamay Ng, PhD 2766-4889 Shamay.Ng@inet.polyu.edu.hk

Locations
Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong
Contact: Shamay Ng, PhD    2766-4889    Shamay.Ng@inet.polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Shamay S.M. Ng, Assistant Professor, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01200030     History of Changes
Other Study ID Numbers: DHSC_NG, DHSC_NG_001
Study First Received: September 10, 2010
Last Updated: September 10, 2010
Health Authority: Hong Kong: The Hong Kong Polytechnic University

Keywords provided by The Hong Kong Polytechnic University:
Sitting balance
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 26, 2014