NCT01942772

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.

Trial Health

55
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Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
Last Updated

September 16, 2013

Status Verified

March 1, 2013

Enrollment Period

1 month

First QC Date

August 27, 2013

Last Update Submit

September 11, 2013

Conditions

StrokeAnkle Injuries

Keywords

powered ankle-foot orthosismechanical structureoptimizationdorsiflexionplantar flexiongaitservomotorankle rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

experimental test of healthy subjects

EXPERIMENTAL

wearing experiment，motion experiment

Device: Ankle-Foot Orthosis

Interventions

Ankle-Foot OrthosisDEVICE
experimental test of healthy subjects

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ankle joint injuries about dorsiflexion and plantar flexion
  • Ability to keep balance independently

You may not qualify if:

  • ankle joint injuries about varus and valgus rehabilitation
  • two assistants needed while walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Institute of Technology

Beijing, Beijing Municipality, 100081, China

Location

Related Links

MeSH Terms

Conditions

StrokeAnkle Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 16, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Last Updated

September 16, 2013

Record last verified: 2013-03

Locations

CN(1)