Interactive Exoskeleton Robot for Walking - Ankle Joint

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Ankle Robot with Power Assistance; Device: Sham

• Registration Number: NCT02471248
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.

Detailed Description

In this clinical trial, participated stroke patients will be divided into two groups: Robotic group and Sham group. Stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. Robotic group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. A series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.

Study Timeline

• Study Start: 2015-05-27
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-15
• Primary Completion: 2016-10-14
• Study Completion: 2016-12-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Ischemic or hemorrphagic stroke with drop foot problem.
2. Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination > 21)
3. Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category > 3, Berg Balance Scale > 40)

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Exclusion Criteria

1. Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
2. Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
3. Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the follow-up.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ankle Robot with Power Assistance	Ankle Robot with Power Assistance	In this experimental group, the Ankle Robot assists the ankle dorsiflexion when the stroke patients voluntarily perform the swing phase gait movement.
Sham group	Sham	In this sham group, the Ankle Robot provides very low assistance to generate tactile feedback to the stroke patients indicating they are performing the swing phase gait movement, but no assistance will be given to support their ankle dorsiflexion.

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Category	3-month follow-up	Assesses postural stability during various walking tasks
6-minute Walk Test	3-month follow-up	Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	3-month follow-up	A 14-item objective measure designed to assess static balance and fall risk in adult populations
Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity)	3-month follow-up	Evaluates and measures recovery in post-stroke hemiplegic patients
Kinematic and Kinetic Gait Motion Capture	3-month follow-up	Gait pattern will be recorded when the stroke patient is walking under three conditions: (1) without the Ankle Robot, (2) with the Idle Ankle Robot, and (3) with the Powered Ankle Robot.
Modified Ashworth Scale	3-month follow-up	Measures spasticity in patients with lesions of the Central Nervous System
Timed 10 Meter Walk Test	3-month follow-up	Assesses walking speed in meters per second over a short duration
Subjective Feedback Questionnaire	3-month follow-up	Stroke patients will provide subjective feedback about the performance of the Ankle Robot in terms of safety, effectiveness, and their satisfaction after the gait training

Trial Locations

Locations (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong