Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

National Rehabilitation Center, Seoul, Korea

Status and phase: Unknown; Phase 4

Conditions: Spasticity; Stroke

Treatments: Other: Early Inmotion and Botox; Other: Inmotion, then Botox; Other: Botox, then Inmotion; Other: Late Inmotion and Botox

Study type: Interventional

Funder types: Other

Identifiers

NCT02228863

NRC-2014-01-005

Details and patient eligibility

About

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

Enrollment: 348 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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348 participants in 4 patient groups

Early Inmotion and Botox

Experimental group

Description:

Concomitant use of Inmotion and botulinum toxin from the baseline

Treatment:

Other: Early Inmotion and Botox

Botox, then Inmotion

Active Comparator group

Description:

Inmotion training 4 weeks after botulinum toxin injection

Treatment:

Other: Botox, then Inmotion

Inmotion, then Botox

Active Comparator group

Description:

From the baseline Inmotion, then Botox injection at 4 weeks after baseline

Treatment:

Other: Inmotion, then Botox

Late Inmotion and Botox

Active Comparator group

Description:

No intervention, then Inmotion and Botox injection at 4 weeks from the baseline

Treatment:

Other: Late Inmotion and Botox