Constraint-Induced Movement Therapy in Chronic Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

The aim of this study is to evaluate the feasibility of a Home-based Constraint-Induced Movement Therapy (hCIMT) compared to a Modified Constraint-Induced Movement Therapy (mCIMT) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.

Detailed Description

Home-based Constraint Induced Modified Therapy (hCIMT) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
Modified Constraint Induced Modified Therapy (mCIMT) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.

Conditions

Interventions

  • MCIMT Behavioral
    Intervention Desc: This intervention is based on 3 main aspects: intensive training of functional tasks with the affected arm (massed practice) constraint of the un-affected hand through a mitt shaping techniques designed to transfer gains to the real world activities The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT.
    ARM 1: Kind: Experimental
    Label: mCIMT
    Description: 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours ADLs at home (supervised by a caregiver) Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.
  • HCIMT Behavioral
    Intervention Desc: This intervention is based on 3 main aspects: intensive training of functional tasks with the affected arm (massed practice) constraint of the un-affected hand through a mitt shaping techniques designed to transfer gains to the real world activities In this group, a comprehensive set of the material necessary to perform the training at home and a booklet containing an explanation of the exercises that can be done will be provided to subjects. In addition, 2 hospital visits will be scheduled to instruct subjects and caregivers on the training and to update activities (1 visit at the beginning + 1 visit after 1 week).
    ARM 1: Kind: Experimental
    Label: hCIMT
    Description: 2 hours intensive upper limb practice with shaping techniques + 2 hours ADLs supervised by a caregiver. Patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE) 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No
Secondary Wolf Motor Function Test (WMFT) 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No
Secondary Nine Hole Peg Test (NHPT 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No
Secondary Motor Activity Log (MAL) 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No
Secondary Stroke Impact Scale 3.0 (SIS 3.0) 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No
Secondary Motor cortex excitability (single pulse and paired pulse TMS) 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No
Secondary NIRS (Near Infrared Spectroscopy) NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair. 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up No

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