StrokeNCT05159635
Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
A study testing Active Living programme and wearable technical aids and Wearable technical aids in people with Stroke and Foot Drop (Acquired), run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Foot Drop (Acquired)
- What is being tested?
- Active Living programme and wearable technical aids and Wearable technical aids
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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)
Who cannot join
- pre-existing orthopedic conditions affecting ambulation
- subjects who are incompetent in giving written consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Foot Drop (Acquired)
- Being tested
- Active Living programme and wearable technical aids, Wearable technical aids
- Keywords
- Wearable
- Medical subject headings
- Stroke, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Living programme and wearable technical aidsDevice
attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.
Wearable technical aidsDevice
apply wearable technical aids for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Living programme and wearable technical aids | Experimental | Active Living programme and wearable technical aids Receives: Device: Active Living programme and wearable technical aids |
| Wearable technical aids | Active comparator | Wearable technical aids Receives: Device: Wearable technical aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before intervention, 8 weeks (after intervention )
Secondary outcomes (1)
Change score in 10 meters walk Test
10 meters walk time
Measured: before intervention,8 weeks (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Feb 2018
- Primary completion1 Jun 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital, Chinese University of Hong Kong
- Responsible party
- Principal investigator, Marko Chan, Kowloon Hospital, Hong Kong
- Investigators
- Marko Chan, MSc, Principal investigator, Community Rehabilitation Service Supoort Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159635
- Sponsor's protocol ID
- KC/KE-17-0187/FR-3
- Status last verified
- Dec 2021
- First submitted
- 4 Aug 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05159635
- Acronym / sponsor ID
- KC/KE-17-0187/FR-3
- Conditions
- Stroke, Foot Drop (Acquired)
- Keywords
- Wearable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital, Chinese University of Hong Kong
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Living programme and wearable technical aids | Experimental | Device: Active Living programme and wearable technical aidsActive Living programme and wearable technical aids |
| Wearable technical aids | Active comparator | Device: Wearable technical aidsWearable technical aids |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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)
Key exclusion criteria (2 listed)
- pre-existing orthopedic conditions affecting ambulation
- subjects who are incompetent in giving written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Living programme and wearable technical aidsattend 6 weeks active living programme and apply wearable technical aids for 8 weeks. | Device | Active Living programme and wearable technical aids |
| Wearable technical aidsapply wearable technical aids for 8 weeks. | Device | Wearable technical aids |
Primary outcome
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
1 secondary outcome
Change score in 10 meters walk Test
Time frame: before intervention,8 weeks (after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Chan, MSc principal investigator
Community Rehabilitation Service Supoort Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Living programme and wearable technical aids and Wearable technical aids in people with Stroke and Foot Drop (Acquired), run by Kowloon Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30) (time frame: before intervention, 8 weeks (after intervention )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.