Back to resultsCombining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
Primary Purpose
Stroke, Foot Drop (Acquired)
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Active Living programme and wearable technical aids
Wearable technical aids
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Wearable
Eligibility Criteria
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
Sites / Locations
- Community Rehabilitation Service Support Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Living programme and wearable technical aids
Wearable technical aids
Arm Description
Active Living programme and wearable technical aids
Wearable technical aids
Outcomes
Primary Outcome Measures
Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30)
The quality of life scale for the people with stroke
Secondary Outcome Measures
Change score in 10 meters walk Test
10 meters walk time
Full Information
NCT ID
NCT05159635
First Posted
August 4, 2021
Last Updated
December 10, 2021
Sponsor
Kowloon Hospital, Hong Kong
Collaborators
Kwong Wah Hospital, Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05159635
Brief Title
Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kowloon Hospital, Hong Kong
Collaborators
Kwong Wah Hospital, Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Foot Drop (Acquired)
Keywords
Wearable
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Living programme and wearable technical aids
Arm Type
Experimental
Arm Description
Active Living programme and wearable technical aids
Arm Title
Wearable technical aids
Arm Type
Active Comparator
Arm Description
Wearable technical aids
Intervention Type
Device
Intervention Name(s)
Active Living programme and wearable technical aids
Intervention Description
attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Wearable technical aids
Intervention Description
apply wearable technical aids for 8 weeks.
Primary Outcome Measure Information:
Title
Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30)
Description
The quality of life scale for the people with stroke
Time Frame
before intervention, 8 weeks (after intervention )
Secondary Outcome Measure Information:
Title
Change score in 10 meters walk Test
Description
10 meters walk time
Time Frame
before intervention,8 weeks (after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marko Chan, MSc
Organizational Affiliation
Community Rehabilitation Service Supoort Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Rehabilitation Service Support Centre
City
Kowloon
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
We'll reach out to this number within 24 hrs