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Completed

NCT Number: NCT02345525

Constraint-Induced Movement Therapy in Chronic Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ferrara University Hospital

Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years and < 80 years
  • diagnosis of first ischemic stroke
  • stroke onset > 6 months prior to study enrollment
  • upper extremity hemiparesis with impairment of hand and/or arm:
  • active wrist extension ≥20º
  • active metacarpophalangeal- and interphalangeal-joints extension ≥ 10°
  • muscle tone assessed by the Modified Ashworth Scale (MAS) ≤ 2
  • pain assessed by the Visual Analogue Scale (VAS) <4

Exclusion criteria

  • anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
  • impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
  • contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
  • neurological or psychiatric pathology
  • severe cardio-pulmonary, renal, hepatic diseases
  • pregnancy

Treatment and study plan

mCIMT

Behavioral

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.

hCIMT

Behavioral

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).

Primary outcomes

  1. Changes from baseline in Fugl-Meyer Upper Extremity (FM-UE)

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.

Secondary outcomes

  1. Wolf Motor Function Test (WMFT)

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    Quantitative measure of upper extremity motor ability through timed and functional tasks.

  2. Nine Hole Peg Test (NHPT

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    Measures finger dexterity

  3. Motor Activity Log (MAL)

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.

  4. Stroke Impact Scale 3.0 (SIS 3.0)

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    Self-assessment questionnaire assesses health status following stroke

  5. Motor cortex excitability (single pulse and paired pulse TMS)

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    Single-Pulse TMS will be used to study cortical-spinal tract excitability in primary motor cortex (M1).

    Paired-pulse TMS Paired-Pulse TMS will be used to study intracortical excitability.

  6. 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.

    Time frame: 1)A week prior to treatment beginning 2) the week after the end of treatment 4) at 3 months follow-up

    For the NIRS it will use an 32-channel NIRS imaging equipment which consist of 16 pairs of emitting and detecting optical fibers attached to a custom-made head cap placed on primary motor cortex.

    NIRS measurements will be performed during 6 cycles of 15s hand reaching and grasping and 45s resting while sitting on a chair.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

The Feasibility of a Home-based Constraint-Induced Movement Therapy Program in Chronic Stroke Survivors.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2015
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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