Upper Extremity Rehabilitation Using Robot and Botulinum Toxin

NCT ID: NCT02228863

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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

Detailed Description

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Conditions

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Stroke Spasticity

Keywords

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Stroke Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Inmotion and Botox

Concomitant use of Inmotion and botulinum toxin from the baseline

Group Type EXPERIMENTAL

Early Inmotion and Botox

Intervention Type OTHER

Concomitant use of Inmotion and Botox from the baseline

Botox, then Inmotion

Inmotion training 4 weeks after botulinum toxin injection

Group Type ACTIVE_COMPARATOR

Botox, then Inmotion

Intervention Type OTHER

At baseline Botox injection and 4 weeks after Inmotion

Inmotion, then Botox

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

Group Type ACTIVE_COMPARATOR

Inmotion, then Botox

Intervention Type OTHER

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

Late Inmotion and Botox

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

Group Type ACTIVE_COMPARATOR

Late Inmotion and Botox

Intervention Type OTHER

No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection

Interventions

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Early Inmotion and Botox

Concomitant use of Inmotion and Botox from the baseline

Intervention Type OTHER

Botox, then Inmotion

At baseline Botox injection and 4 weeks after Inmotion

Intervention Type OTHER

Inmotion, then Botox

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

Intervention Type OTHER

Late Inmotion and Botox

No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Joon-Ho Shin

Team manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon-Ho Shin, MS

Role: PRINCIPAL_INVESTIGATOR

National Rehabilitation Center

Locations

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National Rehabilitation Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Joon-Ho Shin, MS

Role: CONTACT

Phone: 82-2-901-1884

Email: [email protected]

Facility Contacts

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Joon-Ho Shin, MS

Role: primary

References

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Shin JH, Park G, Kim H, Cho DY, Kwon S. Combined effects and timing of robotic training and botulinum toxin on upper limb spasticity and motor function: a single-blinded randomized controlled pilot study. J Neuroeng Rehabil. 2025 Mar 6;22(1):50. doi: 10.1186/s12984-025-01584-1.

Reference Type DERIVED
PMID: 40050906 (View on PubMed)

Related Links

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http://nrc.go.kr

Site of the present study

Other Identifiers

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NRC-2014-01-005

Identifier Type: -

Identifier Source: org_study_id