StrokeNCT01942772
A Powered Ankle Foot Rehabilitation Orthosis
A study testing Ankle-Foot Orthosis in people with Stroke and Ankle Injuries, run by Beijing Institute of Technology at 1 site in China.
Trial summary
Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ankle Injuries
- What is being tested?
- Ankle-Foot Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Feb 2013
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ankle joint injuries about dorsiflexion and plantar flexion
- Ability to keep balance independently
Who cannot join
- ankle joint injuries about varus and valgus rehabilitation
- two assistants needed while walking
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Institute of Technology
Beijing, Beijing Municipality, 100081
About this study
Official title: Design of A Powered Ankle Foot Orthoses for Ankle Rehabilitation
Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. The mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.
- Conditions
- Stroke, Ankle Injuries
- Being tested
- Ankle-Foot Orthosis
- Keywords
- powered ankle-foot orthosis, mechanical structure, optimization, dorsiflexion, plantar flexion, gait, servomotor, ankle rehabilitation
- Medical subject headings
- Stroke, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle-Foot OrthosisDevice
| Study group | Role | What they receive |
|---|---|---|
| experimental test of healthy subjects | Experimental | wearing experiment，motion experiment Receives: Device: Ankle-Foot Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
good performance of the ankle foot orthosis
Two researchers wore the ankle foot orthosis without any motion to test the rationality of design size and wearing coordination；motion experiment without load was carried out to test the stability of transmission structure and effectiveness of motor control. The ankle foot orthosis was fixed on a table.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- China Rehabilitation Research Center
- Responsible party
- Principal investigator, Yang Bai, Beijing Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942772
- Sponsor's protocol ID
- byang421
- Status last verified
- Mar 2013
- First submitted
- 27 Aug 2013
- Last updated
- 16 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of A Powered Ankle Foot Orthoses for Ankle Rehabilitation
- ClinicalTrials.gov ID
- NCT01942772
- Acronym / sponsor ID
- byang421
- Conditions
- Stroke, Ankle Injuries
- Keywords
- powered ankle-foot orthosis, mechanical structure, optimization, dorsiflexion, plantar flexion, gait, servomotor, ankle rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Beijing Institute of TechnologyUniversity, hospital or other
- Collaborators
- China Rehabilitation Research Center
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- First posted
- 16 Sep 2013 (estimated)
- 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.
Ankle rehabilitation training becomes a tough question for the patients with ankle joint injuries especially with the hemiplegia after stroke. Here a novel powered ankle foot orthoses which can provide ankle dorsiflexion and plantar flexion assistant using electric motor is proposed in this paper. The mechanical structure of the orthoses includes wearing parts, ankle joint hinged part, driving unit, transmission mechanism and sensing units. This study provides a new method for ankle foot orthoses design and has great significance for ankle rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental test of healthy subjects | Experimental | Device: Ankle-Foot Orthosiswearing experiment，motion experiment |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ankle joint injuries about dorsiflexion and plantar flexion
- Ability to keep balance independently
Key exclusion criteria (2 listed)
- ankle joint injuries about varus and valgus rehabilitation
- two assistants needed while walking
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 |
|---|---|---|
| Ankle-Foot Orthosis | Device | experimental test of healthy subjects |
Primary outcome
good performance of the ankle foot orthosis
Time frame: one month
Two researchers wore the ankle foot orthosis without any motion to test the rationality of design size and wearing coordination；motion experiment without load was carried out to test the stability of transmission structure and effectiveness of motor control. The ankle foot orthosis was fixed on a table.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
- WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke PatientsLink provided by the sponsor.
- Rehabilitation of Early Stroke Patients Using an AFO: an RCTLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle-Foot Orthosis in people with Stroke and Ankle Injuries, run by Beijing Institute of Technology at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2013. 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 China. 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?
Results are not available in the source record.
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?
good performance of the ankle foot orthosis (time frame: one month). 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 Sep 2013.