A Powered Ankle Foot Rehabilitation Orthosis | NCT01942772

Studies
A Powered Ankle Foot Rehabilitation Orthosis

NCT01942772

Sponsor

Beijing Institute of Technology

Status

Unknown status

Last Update Posted

Sep 16, 2013Estimated

Enrollment

2Estimated

Phase

Not Applicable

Conditions

Stroke
Ankle Injuries

Interventions

Ankle-Foot Orthosis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Feb 2013Actual

Completion Date

Not provided

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Sep 11, 2013

First Posted Date

Sep 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2013

Last Update Posted Date

Sep 16, 2013Estimated

Name	Class
China Rehabilitation Research Center	OTHER_GOV

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental test of healthy subjects	Experimental	wearing experiment，motion experiment	Device: Ankle-Foot Orthosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ankle-Foot Orthosis	Device		experimental test of healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Institute of Technology		Beijing	Beijing Municipality	100081	China

References Module

Citations

Not provided

Label	URL
WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients	View source
Rehabilitation of Early Stroke Patients Using an AFO: an RCT	View source

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D020521	Stroke
D016512	Ankle Injuries