Clinical trial NCT02471248: Interactive Exoskeleton Robot for Walking - Ankle Joint
Official title: Interactive Exoskeleton Robot for Walking - Ankle Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Innovation and Technology Commission, Hong Kong
First posted: 2015-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

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.

Primary outcomes:
measure: 6-minute Walk Test
timeFrame: 3-month follow-up
measure: Functional Ambulation Category
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Timed 10 Meter Walk Test
timeFrame: 3-month follow-up
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity)
timeFrame: 3-month follow-up
measure: Berg Balance Scale
timeFrame: 3-month follow-up
measure: Modified Ashworth Scale
timeFrame: 3-month follow-up
measure: Kinematic and Kinetic Gait Motion Capture
timeFrame: 3-month follow-up
measure: Subjective Feedback Questionnaire
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond KY Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.