Clinical trial NCT03465267: Comparisons of Two Types of Armeo Robot for Upper Extremities
Official title: Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
upper extremity rehabilitation robot
stroke rehabilitation
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2018-03-14
Enrollment: 20
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 two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function

Detailed description: The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist.

Thus the results from this study might suggest usefulness of motorized robot.

Eligibility criteria: Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 3 months
* 26 ≤ Fugl-Meyer Assessment score ≤ 50
* 3 ≤ Shoulder or elbow MRC scale ≤ 4
* Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+
* 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 Wolf motor function test
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: Stroke impact scale
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: 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: % maximal voluntary contraction of upper extremity muscles during reaching task
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Behavioral activation system/behavioral inhibition system scale
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Beck depression index
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Intrinsic motivation inventory
timeFrame: baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Stroke rehabilitation motivation scale
timeFrame: 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:
citation: Park JH, Park G, Kim HY, Lee JY, Ham Y, Hwang D, Kwon S, Shin JH. A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study. J Neuroeng Rehabil. 2020 Oct 19;17(1):137. doi: 10.1186/s12984-020-00763-6.