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Completed

NCT Number: NCT02749500

Early Independent Adaptive Arm and Hand Rehab

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.

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Key information

Conditions

Post-stroke Hemiparesis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Occupational Therapy (OT)

Other

Standard of care occupational therapy for stroke recovery

m2 BAT

Device

Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Primary outcomes

  1. Performance tasks of the Fugl-Meyer Scale (FMS)

    Time frame: 12 Weeks

    This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.

  2. Upper extremity functional ability measured with Modified Rankin Scale

    Time frame: 12 Weeks

  3. Stroke-related quality of life measured with the Stroke Impact Scale

    Time frame: 12 Weeks

  4. Spasticity measured using the Modified Ashworth Scale

    Time frame: 12 Weeks

  5. Range of motion will be measured using video

    Time frame: 12 Weeks

    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.

  6. Upper extremity functional ability measured using the Wolf Motor Function Test

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 25, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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