Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Spasticity
• Intervention / Treatment: Other: Early Inmotion and Botox; Other: Botox, then Inmotion; Other: Inmotion, then Botox; Other: Late Inmotion and Botox

• Study Type: Interventional
• Enrollment (Anticipated): 348
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • Recruiting
    • National Rehabilitation Center
    • Contact: Joon-Ho Shin, MS; Phone Number: 82-901-1884; Email: asfreelyas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• History of surgery of affected upper limb
• Fracture of affected upper limb
• Recent history of botulinum toxin injection within 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of Fugl-Meyer Assessment	Fugl-Meyer Assessment change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic data	Kinematic data from motion analysis (Vicon) Kinematic data from Inmotion	Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline
Spasticity of elbow and shoulder joint	Modified Ashworth scale of elbow and shoulder joint Modified Tardieu scale of elbow and shoulder joint	baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
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	In terms of motivation	baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Controlled Oral Word Association Test	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	baseline, 5ays of Inmotion, 20 days of Inmotion
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	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	baseline, 5days after Inmotion, 20 days after Inmotion.

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Publications and helpful links

Helpful Links

• Site of the present study

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: August 23, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 27, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Stroke; Spasticity
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: NRC-2014-01-005