Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

Sponsor

National Rehabilitation Center, Seoul, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT02228863

Collaborator

(none)

348

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.

Condition or Disease	Intervention/Treatment	Phase
Stroke Spasticity	Other: Early Inmotion and Botox Other: Botox, then Inmotion Other: Inmotion, then Botox Other: Late Inmotion and Botox	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

348 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Inmotion and Botox Concomitant use of Inmotion and botulinum toxin from the baseline	Other: Early Inmotion and Botox Concomitant use of Inmotion and Botox from the baseline
Active Comparator: Botox, then Inmotion Inmotion training 4 weeks after botulinum toxin injection	Other: Botox, then Inmotion At baseline Botox injection and 4 weeks after Inmotion
Active Comparator: Inmotion, then Botox From the baseline Inmotion, then Botox injection at 4 weeks after baseline	Other: Inmotion, then Botox Inmotion from the baseline, then Botox injection at 4 weeks after baseline
Active Comparator: Late Inmotion and Botox No intervention, then Inmotion and Botox injection at 4 weeks from the baseline	Other: Late Inmotion and Botox No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection

Outcome Measures

Primary Outcome Measures

Change of Fugl-Meyer Assessment [Fugl-Meyer Assessment change from baseline at 8 weeks]

Secondary Outcome Measures

Kinematic data [Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline]
Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion
Spasticity of elbow and shoulder joint [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint
Medical research council scale of elbow and shoulder joint strength [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
Painless range of motion of elbow and shoulder joint [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
numeric rating scale of pain of elbow and shoulder joint [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
Associated reaction rating scale [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
surface electromyography data from bilateral upper extremities [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
Behavioral activation system/behavioral inhition system scale [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
In terms of motivation
Controlled Oral Word Association Test [baseline, 5ays of Inmotion, 20 days of Inmotion]
Controlled Oral Word Association Test during baseline, 5 days of Inmotion, 20 days of Inmotion. The test was done at rest and with Inmotion trial
Fugl-Meyer Assessment [Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline]
Stroke impact scale [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
Beck's depression index [baseline, 4 weeks, 8 weeks, and 12 weeks from baseline]
Satisfaction about the intervention [baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline]
Adverse event [From baseline to 12 weeks from the baseline]
Digit span test [baseline, 5days after Inmotion, 20 days after Inmotion.]
Digit span test(forward, backward) during baseline, 5 days of Inmotion, 20 days of Inmotion. The test was done at rest and with Inmotion trial

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hemiplegic patients secondary to first cerebrovascular accidents
Shoulder or Elbow flexor spasticity above or modified ashworth scale 1+
Cognitively intact enough to understand and follow the instructions from the investigator