NCT02131909

Brief Summary

This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

April 28, 2014

Last Update Submit

May 22, 2023

Conditions

Keywords

unilateral cerebral palsychildrenupper-limbmirror therapybimanual coordinationkinematics analysis

Outcome Measures

Primary Outcomes (1)

  • Measurement of the AHA (Assisting Hand Assessment) score

    5 weeks

Secondary Outcomes (4)

  • Evolution of the AHA score

    baseline, 5 weeks, 10 weeks

  • Measurement of the maximal grasp and pinch strength

    baseline, 5 weeks, 10 weeks

  • Qualitative and quantitative measurement of movement

    baseline, 5 weeks, 10 weeks

  • Measurement of the manual ability

    baseline, 5 weeks, 10 weeks

Study Arms (2)

mirror therapy

EXPERIMENTAL

5 sessions mirror therapy 15 minutes per week for 5 weeks

Procedure: mirror therapy

bimanual rehabilitation exercises

PLACEBO COMPARATOR

5 sessions control therapy 15 minutes per week for 5 weeks

Procedure: bimanual rehabilitation exercises

Interventions

During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image

mirror therapy

During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands

bimanual rehabilitation exercises

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Unilateral spastic cerebral palsy as defined by SCPE (Surveillance of Cerebral Palsy in Europe)
  • Aged 7 to 17 years
  • MACS (Manual Ability Classification System) 1 to 3
  • Extension of the wrist more than 10°
  • Free, informed and written consent of the parents
  • Free, informed and written consent of the child
  • affiliated, via his/her parents, to the Social Security regime

You may not qualify if:

  • Other neuromuscular disorders known
  • Cognitive impairment hampering the understanding of instructions
  • Upper-limb pain (EVA score \>3)
  • Restriction of passive range of motion
  • Visual impairment not allowing the visualization of the upper limb in the mirror

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

Location

Related Publications (1)

  • Gaillard F, Cretual A, Cordillet S, Le Cornec C, Gonthier C, Bouvier B, Heyman R, Marleix S, Bonan I, Rauscent H. Kinematic motion abnormalities and bimanual performance in children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Aug;60(8):839-845. doi: 10.1111/dmcn.13774. Epub 2018 Apr 27.

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Hélène HR Rauscent

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 6, 2014

Study Start

February 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2017

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations