Clinical trial NCT04054700: The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients
Official title: The Effect of Upper Limb Rehabilitation on the Application of Proximal Upper Rehabilitation Robot and Distal Upper Rehabilitation Robot With Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: upper limb rehabilitation
stroke
proximal upper rehabilitation robot
distal upper rehabilitation robot
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2019-08-13
Enrollment: 68
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with stroke patients


Eligibility criteria: Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 3 months
* 29 ≤ Fugl-Meyer Assessment score
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* History of surgery of affected upper limb
* Fracture of affected upper limb

Primary outcomes:
measure: Wolf motor function test
timeFrame: change from baseline at 4 weeks
measure: Fugl-Meyer Assessment
timeFrame: change from baseline at 4 weeks
Secondary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Motor activity log
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Action reach arm test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Motor status score
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Box and block test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Wolf motor function test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Mean velocity of upper extremity during reaching task
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Curvature of upper extremity during reaching task
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Jerk of upper extremity during reaching task
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Motor evoked potential over motor cortex of the affected side
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Stroke impact scale 3.0
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References: