CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot | NCT03808428

Studies
CUHK Jockey Club HOPE 4 Care Programme - Ankle Robot

NCT03808428

Sponsor

Chinese University of Hong Kong

Status

Unknown status

Last Update Posted

Jan 17, 2019Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Ankle Group

Countries

Hong Kong

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Dec 20, 2018

First Submission Date that Met QC Criteria

Jan 15, 2019

First Posted Date

Jan 17, 2019Actual

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

Jan 15, 2019

Last Update Posted Date

Jan 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Raymond KY Tong, Professor and Chairman, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Name	Class
The Hong Kong Jockey Club Charities Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Hong Kong Jockey Club Charities Trust has supported CUHK to launch a three-year project 'CUHK Jockey Club HOPE4Care Programme' to implement four evidence-based advanced rehabilitation technologies in 40 local elderly day care centres and rehabilitation centres, to benefit the community. The Exoskeleton Ankle Robot is a robot-assisted Ankle-Foot-Orthosis to facilitate gait training of person after stroke with drop foot.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ankle Group	Experimental	Integrated with force and motion sensors to identify gait phase and classify user walking intention using machine learning control algorithm.	Device: Ankle Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ankle Group	Device	Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.	Ankle Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment Lower Extremity (FMA-LE)		3-month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Functional Ambulation Classification (FAC)		3-month follow-up
Modified Ashworth Scale (MAS)		3-month follow-up
Berg Balance Scale (BBS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have the ability to walk on the ground independently or with one personal assistance with or without walking aids
able to understand simple commends

Exclusion Criteria:

have other neurological, neuromuscular, and orthopedic diseases
uncontrolled cardiovascular or respiratory disorders
moderate to severe contractures in the lower extremities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Raymond Tong, PhD	Contact	+85239438454		kytong@cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Raymond Tong, PhD	Department of Biomedical Engineering, CUHK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Biomedical Engineering, The Chinese University of Hong Kong	Recruiting	Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided