NCT05159635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

1.3 years

First QC Date

August 4, 2021

Last Update Submit

December 10, 2021

Conditions

Keywords

Wearable

Outcome Measures

Primary Outcomes (1)

  • 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

    before intervention, 8 weeks (after intervention )

Secondary Outcomes (1)

  • Change score in 10 meters walk Test

    before intervention,8 weeks (after intervention)

Study Arms (2)

Active Living programme and wearable technical aids

EXPERIMENTAL

Active Living programme and wearable technical aids

Device: Active Living programme and wearable technical aids

Wearable technical aids

ACTIVE COMPARATOR

Wearable technical aids

Device: Wearable technical aids

Interventions

attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.

Active Living programme and wearable technical aids

apply wearable technical aids for 8 weeks.

Wearable technical aids

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • pre-existing orthopedic conditions affecting ambulation
  • subjects who are incompetent in giving written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Rehabilitation Service Support Centre

Kowloon, Hong Kong

Location

MeSH Terms

Conditions

StrokePeroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Marko Chan, MSc

    Community Rehabilitation Service Supoort Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Occupational Therapist

Study Record Dates

First Submitted

August 4, 2021

First Posted

December 16, 2021

Study Start

February 1, 2018

Primary Completion

June 1, 2019

Study Completion

October 1, 2019

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations