NCT02808195

Brief Summary

The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 24, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

7.6 years

First QC Date

May 24, 2016

Last Update Submit

September 18, 2024

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyNeurological RehabilitationUpper Extremity

Outcome Measures

Primary Outcomes (1)

  • Performance Change assessed by Kinematic analysis

    Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.

    baseline, 2 months and 6 months

Secondary Outcomes (16)

  • score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)

    baseline, 1 months, 2 months and 6 months

  • score change of Melbourne Assessment 2 (MA2)

    baseline, 1 months, 2 months and 6 months

  • score change of Pediatric Motor Activity Log-Revised (PMAL-R)

    baseline, 1 months, 2 months and 6 months

  • score change of ABILHAND-kids

    baseline, 1 months, 2 months and 6 months

  • score change of Functional Independence Measures for children (WeeFIM)

    baseline, 1 months, 2 months and 6 months

  • +11 more secondary outcomes

Study Arms (2)

constraint-induced therapy

EXPERIMENTAL

training of the more affected arm and restraint the less affected arm

Other: Constraint-induced therapy

kinect-based constraint-induced therapy

EXPERIMENTAL

training of the more affected arm and restraint the less affected arm by kinect-game

Other: kinect-based constraint-induced therapy

Interventions

Constraint-induced therapyOTHER
constraint-induced therapy
kinect-based constraint-induced therapyOTHER
kinect-based constraint-induced therapy

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • diagnosed with congenital hemiplegic or CP with one more affected side
  • considerable nonuse of the affected upper limb.

You may not qualify if:

  • no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
  • no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  • no injections of botulinum toxin type A or operations on the upper limb within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Related Publications (2)

  • Shih TY, Wang TN, Shieh JY, Lin SY, Ruan SJ, Tang HH, Chen HL. Comparative effects of kinect-based versus therapist-based constraint-induced movement therapy on motor control and daily motor function in children with unilateral cerebral palsy: a randomized control trial. J Neuroeng Rehabil. 2023 Jan 27;20(1):13. doi: 10.1186/s12984-023-01135-6.

    PMID: 36703170DERIVED

  • Chen HL, Lin SY, Yeh CF, Chen RY, Tang HH, Ruan SJ, Wang TN. Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy. Front Bioeng Biotechnol. 2021 Oct 26;9:755506. doi: 10.3389/fbioe.2021.755506. eCollection 2021.

    PMID: 34765593DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Hao-Ling Chen

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2016

First Posted

June 21, 2016

Study Start

August 1, 2016

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

TW(1)