Back to resultsA Powered Ankle Foot Rehabilitation Orthosis
Primary Purpose
Stroke, Ankle Injuries
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ankle-Foot Orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring powered ankle-foot orthosis, mechanical structure, optimization, dorsiflexion, plantar flexion, gait, servomotor, ankle rehabilitation
Eligibility Criteria
Inclusion Criteria:
- ankle joint injuries about dorsiflexion and plantar flexion
- Ability to keep balance independently
Exclusion Criteria:
- ankle joint injuries about varus and valgus rehabilitation
- two assistants needed while walking
Sites / Locations
- Beijing Institute of Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental test of healthy subjects
Arm Description
wearing experiment，motion experiment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01942772
First Posted
August 27, 2013
Last Updated
September 11, 2013
Sponsor
Beijing Institute of Technology
Collaborators
China Rehabilitation Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01942772
Brief Title
A Powered Ankle Foot Rehabilitation Orthosis
Official Title
Design of A Powered Ankle Foot Orthoses for Ankle Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Institute of Technology
Collaborators
China Rehabilitation Research Center
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ankle Injuries
Keywords
powered ankle-foot orthosis, mechanical structure, optimization, dorsiflexion, plantar flexion, gait, servomotor, ankle rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental test of healthy subjects
Arm Type
Experimental
Arm Description
wearing experiment，motion experiment
Intervention Type
Device
Intervention Name(s)
Ankle-Foot Orthosis
Primary Outcome Measure Information:
Title
good performance of the ankle foot orthosis
Description
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.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ankle joint injuries about dorsiflexion and plantar flexion
Ability to keep balance independently
Exclusion Criteria:
ankle joint injuries about varus and valgus rehabilitation
two assistants needed while walking
Facility Information:
Facility Name
Beijing Institute of Technology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100081
Country
China
12. IPD Sharing Statement
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT01087957?term=ankle-foot+orthosis&rank=1
Description
WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
URL
http://clinicaltrials.gov/ct2/show/NCT01006772?term=ankle-foot+orthosis&rank=3
Description
Rehabilitation of Early Stroke Patients Using an AFO: an RCT
Learn more about this trial
A Powered Ankle Foot Rehabilitation Orthosis
We'll reach out to this number within 24 hrs