Clinical trial NCT03104881: Comparisons of Two Types of Rehabilitation Robot for Upper Extremities
Official title: Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2017-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)


Eligibility criteria: Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 3 months
* 8 ≤ Fugl-Meyer Assessment score ≤ 30
* Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
* 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: Change of Fugl-Meyer Assessment
timeFrame: Fugl-Meyer Assessment change from baseline at 4 weeks
measure: Wolf motor function test
timeFrame: Fugl-Meyer Assessment change from baseline at 4 weeks
Secondary outcomes:
measure: Wolf motor function test
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Motor status score
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: medical research council scale of upper extremity
timeFrame: baseline
measure: Modified Ashworth scale of upeer extremity
timeFrame: baseline
measure: Pain of upper extremity
timeFrame: from baseline to 4 weeks after baseline
measure: Stroke impact scale
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Smoothness
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Reach Error
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Path Error
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Mean velocity
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Maximum velocity
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Cricle size
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Cricle independence
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Intrinsic motivation inventory
timeFrame: 4 weeks after baseline
measure: stroke rehabilitation motivation scale
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
measure: Beck depression index
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 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: