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

NCT01422005 | Completed DMC

• 2 other identifiers: 11-00118R#: 11-00118
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

Rehabilitation; Fingers; Grasp; Hand; Strength; Brain Infraction; Hand Function; Post Stroke; Neural mechanisms; Motor Control; Motor Function

Outcome Measures

Primary Outcomes (1)

• Measurement of hand function

  The outcome measures using the devices will include: * hand function * range of motion * stiffness * extent of impairment on the affected side * temperature differences between the two sides of the body, and * skin sensitivity to pressure. Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.

  Day 1

Secondary Outcomes (1)

• Measurement of Hand Function

  Day 84

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Simultaneous Bimanual training

Control Group

ACTIVE COMPARATOR

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

Other: Conventional Occupational Therapy

Interventions

Simultaneous Bimanual training 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.

Also known as: Device group, Control group

Experimental group

Conventional Occupational Therapy OTHER

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

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

New York Univeristy School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• John R Rizzo, MD

  New York Univeristy School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 23, 2011
• Study Start: January 1, 2011
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

US (1)