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

NCT ID: NCT01422005

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2019-12-12

Brief Summary

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.

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

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental group

Simultaneous Bimanual training: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices.

Group Type: EXPERIMENTAL

Simultaneous Bimanual training

Intervention Type: OTHER

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.

Control Group

Conventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.

Group Type: ACTIVE_COMPARATOR

Conventional Occupational Therapy

Intervention Type: OTHER

Conventional Occupational Therapy will be given to patients in the control group.

Interventions

Simultaneous Bimanual training

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.

Intervention Type: OTHER

Conventional Occupational Therapy

Conventional Occupational Therapy will be given to patients in the control group.

Intervention Type: OTHER

Other Intervention Names

Device group; Control group; Control Group

Eligibility Criteria

Inclusion Criteria

• Ability to follow study instructions and likely to complete all required visits; ability to comply with the therapy protocol as assessed by the investigator; must be English speaking.
• Subjects must have had a unilateral stroke

Exclusion Criteria

• Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
• Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
• History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
• Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
• Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R Rizzo, MD

Role: PRINCIPAL_INVESTIGATOR

New York Univeristy School of Medicine

Locations

New York Univeristy School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

R#: 11-00118

Identifier Type: OTHER

Identifier Source: secondary_id

11-00118

Identifier Type: -

Identifier Source: org_study_id