Early Independent Adaptive Arm and Hand Rehab

Post-stroke Hemiparesis Clinical Trial

Official title:

Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749500
• Other study ID #: 15-01460
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: January 19, 2019

Study information

• Verified date: March 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.

Description:

This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 19, 2019
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Ability to follow study instructions

• Ability to likely 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.

• Patients who are cognitively impaired.

• Patients who lack capacity to consent.

Related Conditions & MeSH terms

• Paresis
• Post-stroke Hemiparesis
• Stroke

Intervention

Other:
• Conventional Occupational Therapy (OT)
Standard of care occupational therapy for stroke recovery

Device:
• m2 BAT
Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance tasks of the Fugl-Meyer Scale (FMS)	This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.	12 Weeks
Primary	Upper extremity functional ability measured with Modified Rankin Scale		12 Weeks
Primary	Stroke-related quality of life measured with the Stroke Impact Scale		12 Weeks
Primary	Spasticity measured using the Modified Ashworth Scale		12 Weeks
Primary	Range of motion will be measured using video	Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.	12 Weeks
Primary	Upper extremity functional ability measured using the Wolf Motor Function Test		12 Weeks