NCT03184259

Brief Summary

A new lower-limb training system is introduced to enhance the clinical service for post-stroke lower limb rehabilitation and to assist the establishment of public clinical trial in different settings and share experiences on the robot-assisted functional training.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

June 9, 2017

Last Update Submit

February 14, 2019

Conditions

Stroke

Keywords

StrokeExoskeleton RobotRehabilitationAnkle Foot OrthosisKnee BraceFoot Drop

Outcome Measures

Primary Outcomes (1)

  • Functional Ambulatory Category (FAC)

    Functional Ambulatory Category (FAC) is a reliable measurement of independent walking ability on level-ground walking and stair ambulation, which is a good prediction of independent community walking post-stroke (Mehrholz, et al., 2007). FAC consists of 6-level scale: patients with FAC=4 requires supervision in level ground walking, FAC=5 requires supervision only when walking on non-level surface such as stairs.

    Baseline, Post-Training, 3-month follow up

Secondary Outcomes (5)

  • Fugl-Meyer Assessment for Lower-Extremity (FMA-LE)

    Baseline, Post-Training, 3-month follow up

  • Modified Ashworth Scale (MAS)

    Baseline, Post-Training, 3-month follow up

  • Berg Balance Scale (BBS)

    Baseline, Post-Training, 3-month follow up

  • Timed 10-Meter Walk Test (10mWT)

    Baseline, Post-Training, 3-month follow up

  • 6-minute Walk Test (SMWT)

    Baseline, Post-Training, 3-month follow up

Other Outcomes (3)

  • Gait Analysis with EMG Collection

    Baseline, Post-Training

  • Subjective Feedback from Participants

    Post-Training

  • Mini-Mental State Examination (MMSE)

    Baseline

Study Arms (5)

Robotic ankle system

EXPERIMENTAL

Subjects will wear the Ankle Robot during 20-session gait training, power assistance will be provided from the motor to the ankle joint.

Device: Robotic ankle system

Robotic knee system

EXPERIMENTAL

Subjects will wear the Knee Robot during 20-session gait training, power assistance will be provided from the motor to the knee joint.

Device: Robotic knee system

Ankle Sham group

PLACEBO COMPARATOR

Subjects will wear the Ankle Robot during 20-session gait training, but no power assistance will be provided from the motor to the ankle joint.

Device: Robotic ankle system

Knee Sham group

PLACEBO COMPARATOR

Subjects will wear the Knee Robot during 20-session gait training, but no power assistance will be provided from the motor to the knee joint.

Device: Robotic knee system

Health Control

NO INTERVENTION

Healthy subjects will wear the Ankle Robot and/or Knee Robot during walking tasks (with or without power assistance), to collect control data for investigating if there are any effects of the robotic assistance on normal gait pattern.

Interventions

Robotic ankle systemDEVICE

Patients will wear the robotic ankle system and undergo 20-minute over-ground walking and 10-minute stair walking.

Also known as: Ankle Robot
Ankle Sham groupRobotic ankle system
Robotic knee systemDEVICE

Patients will wear the robotic knee system and undergo 20-minute over-ground walking and 10-minute stair walking.

Also known as: Knee Robot
Knee Sham groupRobotic knee system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First episode of stroke,
  • Hemiparesis resulting from a unilateral ischemic or hemorrhagic stroke,
  • Functional Ambulation Category (FAC) \> 2 out of 6, i.e. have ability to walk on the ground independently or under supervision, with or without assistive device,
  • Have sufficient cognition to follow instructions and to understand the content and purpose of the study.

You may not qualify if:

  • Uncontrolled cardiovascular or respiratory disorders,
  • Moderate to serve contractures in the lower extremities,
  • Orthopedic problems or muscle diseases that impair mobility,
  • Difficulty to comply with the study protocol and the gait training schedule, i.e. at least 2 sessions per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (3)

  • Yeung LF, Ockenfeld C, Pang MK, Wai HW, Soo OY, Li SW, Tong KY. Randomized controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke patients wearing ankle-foot-orthosis. J Neuroeng Rehabil. 2018 Jun 19;15(1):51. doi: 10.1186/s12984-018-0394-7.

    PMID: 29914523RESULT

  • Yeung LF, Ockenfeld C, Pang MK, Wai HW, Soo OY, Li SW, Tong KY. Design of an exoskeleton ankle robot for robot-assisted gait training of stroke patients. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:211-215. doi: 10.1109/ICORR.2017.8009248.

    PMID: 28813820RESULT

  • Yeung LF, Lau CCY, Lai CWK, Soo YOY, Chan ML, Tong RKY. Effects of wearable ankle robotics for stair and over-ground training on sub-acute stroke: a randomized controlled trial. J Neuroeng Rehabil. 2021 Jan 29;18(1):19. doi: 10.1186/s12984-021-00814-6.

    PMID: 33514393DERIVED

Related Links

MeSH Terms

Conditions

StrokePeroneal Neuropathies

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Raymond Kai-yu Tong, PhD

    Department of Biomedical Engineering, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Kai-yu Tong, PhD

CONTACT

+852 3943 8454kytong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 12, 2017

Study Start

July 12, 2017

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)