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Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)

Sponsor
Kowloon Hospital, Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT05159635
Collaborator
Kwong Wah Hospital (Other), Chinese University of Hong Kong (Other)
12
Enrollment
1
Location
2
Arms
19.9
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Active Living programme and wearable technical aids
  • Device: Wearable technical aids
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2018
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Living programme and wearable technical aids

Active Living programme and wearable technical aids

Device: 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

Wearable technical aids

Device: Wearable technical aids
apply wearable technical aids for 8 weeks.

Outcome Measures

Primary Outcome Measures

  1. Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30) [before intervention, 8 weeks (after intervention )]

    The quality of life scale for the people with stroke

Secondary Outcome Measures

  1. Change score in 10 meters walk Test [before intervention,8 weeks (after intervention)]

    10 meters walk time

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Community Rehabilitation Service Support Centre Kowloon Hong Kong

Sponsors and Collaborators

  • Kowloon Hospital, Hong Kong
  • Kwong Wah Hospital
  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Marko Chan, MSc, Community Rehabilitation Service Supoort Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marko Chan, Senior Occupational Therapist, Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT05159635
Other Study ID Numbers:
  • KC/KE-17-0187/FR-3
First Posted:
Dec 16, 2021
Last Update Posted:
Dec 16, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marko Chan, Senior Occupational Therapist, Kowloon Hospital, Hong Kong
Wearable
Additional relevant MeSH terms:
Peroneal Neuropathies

Study Results

No Results Posted as of Dec 16, 2021