Interactive Exoskeleton Robot for Walking - Ankle Joint
NCT ID: NCT02471248
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2015-05-27
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Ankle Robot with Power Assistance
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.
Sham group
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.
Sham
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.
Interventions
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Ankle Robot with Power Assistance
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.
Sham
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
85 Years
ALL
No
Sponsors
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Innovation and Technology Commission, Hong Kong
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
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Raymond KY Tong
Professor
Principal Investigators
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Raymond KY Tong, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Biomedical Engineering, CUHK
Locations
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Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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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.
Other Identifiers
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2015.037-T (Ankle)
Identifier Type: -
Identifier Source: org_study_id