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

Stroke Clinical Trial

Official title:

Simultaneous Bimanual Training to Improve Motor Function Post-Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422005
• Other study ID #: 11-00118
• Secondary ID: R#: 11-00118
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: December 12, 2019

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	New York Univeristy School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 84