Clinical trial NCT02772510: Upper Extremity Rehabilitation Using Game Rehabilitation System With Functional Electrical Stimulation for Stroke Patients
Official title: Upper Extremity Rehabilitation Using Game-based Virtual Reality Rehabilitation System (Smart Glove System) With Functional Electrical Stimulation for Stroke Patients : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Hand
Game
Functional electrical stimulation
Virtual reality
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2016-05-13
Enrollment: 54
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: The purpose of the present study was to investigate the effects of game-based virtual reality rehabilitation combined with functional electrical stimulation on distal upper extremity function, and compare the findings to those of functional electrical stimulation in stroke survivors.


Eligibility criteria: Inclusion Criteria:

* first-ever ischemic or hemorrhagic stroke
* wrist extensor of medical research council scale 1\~3
* No clinical evidence of limited passive range of motion of affected wrist

Exclusion Criteria:

* age \<18 years
* severe aphasia resulting in communication difficulties confounding intervention and outcome measures
* severe cognitive impairment resulting cooperation difficulties
* spasticity \> modified Ashworth scale 1+

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: 4 weeks from baseline
measure: Fugl-Meyer Assessment-hand & wrist
timeFrame: 4 weeks from baseline
Secondary outcomes:
measure: Wolf Motor Function Test
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: Fugl-Meyer Assessment upper extremity
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Stroke Impact Scale
timeFrame: baseline, 4 weeks after baseline
measure: Motor Activity Log
timeFrame: baseline, 4 weeks after baseline
measure: Medical research council scale of elbow flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Medical research council scale of wrist flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Range Of Motion of elbow flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Range Of Motion of wrist flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Brunnstrom stage
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Jebsen-Taylor hand function test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Modified Ashworth scale of elbow flexor/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Modified Ashworth scale of wrist flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Modified Tardieu scale of elbow flexor/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Modified Tardieu scale of wrist flexion/extension
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
measure: Adverse events
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:
citation: Lee SH, Lee JY, Kim MY, Jeon YJ, Kim S, Shin JH. Virtual Reality Rehabilitation With Functional Electrical Stimulation Improves Upper Extremity Function in Patients With Chronic Stroke: A Pilot Randomized Controlled Study. Arch Phys Med Rehabil. 2018 Aug;99(8):1447-1453.e1. doi: 10.1016/j.apmr.2018.01.030. Epub 2018 Mar 2.