Interactive Exoskeleton Robot for Walking - Ankle Joint

NCT02471248 | Completed

• 1 other identifier: 2015.037-T (Ankle)
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 6-minute Walk Test

  Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance

  3-month follow-up

• Functional Ambulation Category

  Assesses postural stability during various walking tasks

  3-month follow-up

Secondary Outcomes (6)

• Timed 10 Meter Walk Test

  3-month follow-up

• Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity)

  3-month follow-up

• Berg Balance Scale

  3-month follow-up

• Modified Ashworth Scale

  3-month follow-up

• Kinematic and Kinetic Gait Motion Capture

  3-month follow-up

Study Arms (2)

Ankle Robot with Power Assistance

EXPERIMENTAL

In this experimental group, the Ankle Robot assists the ankle dorsiflexion when the stroke patients voluntarily perform the swing phase gait movement.

Device: Ankle Robot with Power Assistance

Sham group

PLACEBO COMPARATOR

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.

Device: Sham

Interventions

Ankle Robot with Power Assistance DEVICE

Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 \* 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote gait recovery and physical fitness. They will wear the Ankle Robot during the gait training. The motor will synchronise with the paretic-side gait pattern to provide dorsiflexion moment during swing phase, and free the ankle joint when the sole is loaded.

Ankle Robot with Power Assistance

Sham DEVICE

Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 \* 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote physical fitness. They will wear the Ankle Robot during the gait training. The robot will synchronise with the paretic-side gait pattern to the Ankle Robot provides very low assistance which can be barely perceived by the stroke patient but does not suffice to support the ankle dorsiflexion.

Sham group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
• Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the follow-up.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Innovation and Technology Commission, Hong Kong: collaborator

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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: 29914523 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond KY Tong, PhD

  Department of Biomedical Engineering, CUHK

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 15, 2015
• Study Start: May 27, 2015
• Primary Completion: October 14, 2016
• Study Completion: December 31, 2016
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)