Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway in Patients After Knee Arthroplasty
Multi-Modalities Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway of the Proximal Muscles in Patients After Total Knee Arthroplasty
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 2, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2017
CompletedJuly 2, 2017
June 1, 2017
7 months
November 2, 2016
June 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Isometric muscle strength
peak torque (Nm/㎡), Maximal ratio of torque development (RTD) (degree/sec)
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Secondary Outcomes (4)
Change of Cortico-motor Excitability
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Spinal Motor-neuron Excitability
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Cross-sectional area and volume of thigh muscle
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Change of Muscle work
0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Study Arms (2)
Morning walk
EXPERIMENTALRehabilitation using end-effector type gait robot for 5days.
Ground Walker
ACTIVE COMPARATORRehabilitation using walker for 5days.
Interventions
gait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays
gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays
Eligibility Criteria
You may qualify if:
- Patients after Unilateral Total Knee Arthroplasty
You may not qualify if:
- brain disease, spinal cord injury, peripheral neuropathy, myopathy
- Inability to ambulate fully due to muscukoskeletal disorders
- MMSE\<23
- history of arthroplasty surgery on either of legs
- Cardiac pacemaker
- Refusal of participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulsan University Hospital
Ulsan, 682-714, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
November 2, 2016
First Posted
November 11, 2016
Study Start
November 1, 2016
Primary Completion
May 15, 2017
Study Completion
May 15, 2017
Last Updated
July 2, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share