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Light Constraint Induced Therapy Experiment (LICITE)

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated
Phase 3

Conditions

Stroke

Treatments

Other: Standard constraint induced therapy
Other: Light constraint induced therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00839670
P070161

Details and patient eligibility

About

The purpose of this trial is to compare the effect of a modified constraint induced therapy to the treatment described originally by Taub et al.. This study will determine if LICITE will lead to similar improvements than the original described method.

Full description

Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.

The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).

Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years
  • First ischemic or hemorrhagic stroke between 2 and 12 months
  • at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
  • adequate balance while wearing the restraint

Exclusion criteria

  • Major cognitive impairment
  • Prior stroke
  • Excessive fatigability
  • Severe aphasia
  • MAL score ≥ 2,5
  • Specific exclusion criteria for fMRI ancillary study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups

Modified Therapy
Active Comparator group
Treatment:
Other: Light constraint induced therapy
Standard Therapy
Active Comparator group
Treatment:
Other: Standard constraint induced therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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