Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01422005
Other study ID # 11-00118
Secondary ID R#: 11-00118
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date December 2019

Study information

Verified date May 2019
Source New York University School of Medicine
Contact John R Rizzo, M.D
Phone 212.263.0344
Email JohnRoss.Rizzo@nyulangone.org
Is FDA regulated No
Health authority
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 Recruiting
Enrollment 20
Est. completion date December 2019
Est. primary completion date December 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

Study Design


Related Conditions & MeSH terms


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
New York University School of Medicine 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
See also
  Status Clinical Trial Phase
Recruiting NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Recruiting NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT03698357 - Video Balance-based Exercise in Persons With Stroke N/A
Not yet recruiting NCT03956160 - Development and Evaluation of a Patient-centered Transition Program for Stroke Patients, Combining Case Management and Access to an Internet Information Platform N/A
Recruiting NCT03402906 - Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke N/A
Completed NCT03575481 - Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
Recruiting NCT03542188 - TReatment Strategy In Acute Ischemic larGE Vessel STROKE: Prioritize Thrombolysis or Endovascular Treatment N/A
Completed NCT03305731 - Activating Behavior for Lasting Engagement After Stroke N/A
Recruiting NCT02822144 - General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke Phase 3
Active, not recruiting NCT03371290 - Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke N/A
Recruiting NCT03884621 - Enhanced Post-discharge Home-based Care Program (EHP) for Stroke Survivors in Harbin China N/A
Recruiting NCT03294187 - Encouragement-induced Movement Therapy in Daily Life N/A
Enrolling by invitation NCT03259373 - IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation N/A
Recruiting NCT01996137 - VASSTII: An Exploratory Clinical Study on a VASST IITreadmill System for Post Stroke Gait Rehabilitation. N/A
Completed NCT03559829 - Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke N/A