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Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)

U

University Hospital of Mont-Godinne

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Congenital Hemiplegia

Treatments

Other: "HABIT-ILE"

Study type

Interventional

Funder types

Other

Identifiers

NCT01700777
UHMG-IONS-862010

Details and patient eligibility

About

A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University.

Full description

A randomized control trial of "HABIT-ILE" therapy at intensive frequency contrasted with regular frequency intervention. The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2 weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week). Children of all groups will benefit from 90h of intensive treatment (children in regular frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the regular interventions, there is at least one therapist for each child.

Enrollment

40 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • willingness to enter the research program and the testing procedures

Exclusion criteria

  • uncontrolled epilepsy
  • upper limb injections in the upper limb during the last six months / or intend to receive during the training period

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Intensive rehab group
Experimental group
Description:
A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.
Treatment:
Other: "HABIT-ILE"
Regular treatment group
Active Comparator group
Description:
A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours.
Treatment:
Other: "HABIT-ILE"

Trial contacts and locations

1

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Central trial contact

Yannick Bleyenheuft, PhD; Corinne Bleyenheuft, MD resp.

Data sourced from clinicaltrials.gov

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