Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
December 10, 2021 updated by: Marko Chan, Kowloon Hospital, Hong Kong
The Effectiveness of Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA) to Promote Community Participation in Young Stroke With Foot Drop Problem- The Pilot Study
The objective of this study is to evaluate the effectiveness of adopting a home-use Wearable Technical Aids (WTA) with the structured Active Living Program (ALP) to promote community participation in young stroke patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Two groups of patients would receive Wearable Technical Aids Training or Wearable Technical Aids Training and structured Active Living Program (ALP) for 8 sessions.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kowloon, Hong Kong
- Community Rehabilitation Service Support Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-diagnosed with foot drop with tibialis anterior muscle strength between 1 to 3- out of 5 in manual muscle testing for more than six months due to cerebrovascular accident (CVA)
Exclusion Criteria:
- pre-existing orthopedic conditions affecting ambulation
- subjects who are incompetent in giving written consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Living programme and wearable technical aids
|
attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.
|
|
Active Comparator: Wearable technical aids
|
apply wearable technical aids for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30)
Time Frame: before intervention, 8 weeks (after intervention )
|
The quality of life scale for the people with stroke
|
before intervention, 8 weeks (after intervention )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change score in 10 meters walk Test
Time Frame: before intervention,8 weeks (after intervention)
|
10 meters walk time
|
before intervention,8 weeks (after intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marko Chan, MSc, Community Rehabilitation Service Supoort Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
August 4, 2021
First Submitted That Met QC Criteria
December 10, 2021
First Posted (Actual)
December 16, 2021
Study Record Updates
Last Update Posted (Actual)
December 16, 2021
Last Update Submitted That Met QC Criteria
December 10, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KC/KE-17-0187/FR-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.