Study of the Recovery of Muscle Function in the Arm/Hand After a Stroke

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to examine if practicing joint movements using specially designed devices can help in the recovery of muscle function in the arm/hand after a stroke. Subjects may qualify for participation in this study because they had a stroke and have had difficulty using their affected arm/hand ever since.

Detailed Description

Stroke is a leading cause of long-term adult disability in the United States, and hemiparesis is the most common motor impairment that frequently leads to persistent deficits in hand function. The mechanisms of recovery of hand motor function after stroke are poorly understood, and the protocols used in clinical practice lack a solid scientific rationale. The long-term objective of this research is to understand the neural mechanisms underlying the recovery of voluntary motor functions in brain-injured patients in order to provide a more objective and scientific basis to rehabilitation protocols used in clinical practice.
Dr. Preeti Raghavan and Dr. Donald Weisz, both research study doctors, are the named inventors of the devices being used in and investigated as part of this research study. These devices will be used to facilitate the training of either unimanual or bimanual movements that can be used both in the acute and chronic post-stroke period, even when there is little active movement in the affected upper extremity. The specially designed mechanical devices (BAT, PST and WIFIT), Psychophysical methods using an instrumented glove, and electromyographic recordings from upper extremity muscles to investigate the following specific aims in patients with post-stroke hemiparesis will lead to:
- greater extensor muscle activation and out of synergy movement compared with unimanual training facilitated by an external agent (e.g. another person).
- Bimanual training with the specially designed mechanical devices (BAT, PST and WIFIT) over 6 weeks will produce greater functional recovery in the affected upper extremity in patients with post-stroke hemiparesis, compared with conventional therapy.
- The gains in motor control and function will be greater in patients who begin bimanual training in the acute post-stroke phase (0-6) months, compared with those that begin in the chronic post-stroke phase (> 6 months).

Conditions

Interventions

  • Simultaneous Bimanual training Other
    Other Names: Device group; Control group
    Intervention Desc: Patients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices. Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy.
    ARM 1: Kind: Experimental
    Label: Experimental group
    Description: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices.
    ARM 2: Kind: Experimental
    Label: Control Group
    Description: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.
  • Conventional occupational therapy Other
    Other Names: Control Group
    Intervention Desc: Conventional Occupational Therapy will be given to patients in the control group.
    ARM 1: Kind: Experimental
    Label: Control Group
    Description: Conventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Supportive Care
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Measurement of hand function Day 1 No

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