NCT02228863

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
348

participants targeted

Target at P50-P75 for phase_4 stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

2.9 years

First QC Date

August 23, 2014

Last Update Submit

August 27, 2014

Conditions

StrokeSpasticity

Keywords

StrokeSpasticity

Outcome Measures

Primary Outcomes (1)

  • Change of Fugl-Meyer Assessment

    Fugl-Meyer Assessment change from baseline at 8 weeks

Secondary Outcomes (15)

  • Kinematic data

    Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline

  • Spasticity 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

  • +10 more secondary outcomes

Study Arms (4)

Early Inmotion and Botox

EXPERIMENTAL

Concomitant use of Inmotion and botulinum toxin from the baseline

Other: Early Inmotion and Botox

Botox, then Inmotion

ACTIVE COMPARATOR

Inmotion training 4 weeks after botulinum toxin injection

Other: Botox, then Inmotion

Inmotion, then Botox

ACTIVE COMPARATOR

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

Other: Inmotion, then Botox

Late Inmotion and Botox

ACTIVE COMPARATOR

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

Other: Late Inmotion and Botox

Interventions

Early Inmotion and BotoxOTHER

Concomitant use of Inmotion and Botox from the baseline

Early Inmotion and Botox
Botox, then InmotionOTHER

At baseline Botox injection and 4 weeks after Inmotion

Botox, then Inmotion
Inmotion, then BotoxOTHER

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

Inmotion, then Botox
Late Inmotion and BotoxOTHER

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

Late Inmotion and Botox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, Seoul, 142884, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40050906DERIVED

Related Links

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Joon-Ho Shin, MS

    National Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon-Ho Shin, MS

CONTACT

82-2-901-1884asfreelyas@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

August 23, 2014

First Posted

August 29, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2017

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

KR(1)