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Completed

NCT Number: NCT02410629

To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients

The investigators are trying to determine the therapeutic effect of the music glove and conventional hand exercise program to the subacute stroke patients. All participants will be randomized into two groups: AB and BA. They will all exercise at least 3 times a week for 3 weeks with a minimal 3 hours exercise time per week. Participants will receive the other intervention at 3-month post stroke date. Clinical evaluations will be performed at baseline, post therapy after first intervention, 3-week post intervention follow up, 3-month post stroke, post therapy after second intervention, 3-week post second intervention follow up, and 6-month post stroke follow up visits.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine

Irvine, California, 92697, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of a single stroke at least 1 week prior to enrollment
  • Upper Extremity weakness measured on a standard clinical scale
  • No active major psychiatric problems, or neurological/orthopedic problems affecting the stroke affected upper extremity
  • No active major neurological disease other than the stroke
  • Absence of pain in the affected upper extremity

Exclusion criteria

  • Severe tone at the affected upper extremity as measured on a standard clinical scale
  • Severe aphasia as measured on a standard clinical scale
  • Severe reduced level of consciousness
  • Severe sensory/proprioception deficit at the affected upper extremity as measured on a standard clinical scale
  • Currently pregnant
  • Difficulty in understanding or complying with instructions given by the experimenter
  • Inability to perform the experimental task that will be studied
  • Increased pain with movement of the affected upper extremity

Treatment and study plan

Music Glove

Device

Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week.

Conventional hand exercise program

Other

Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week.

Primary outcomes

  1. Box and Block Test

    Time frame: From baseline to end of therapy (3 weeks)

    We compared the change of Box and Block Test scores from baseline evaluation to the end of 3-week of therapy (Intervention 1), and from 12-week post-stroke to end of 3-week therapy (Intervention 2). Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicates a better outcome.

Secondary outcomes

  1. Fugl-Meyer Motor Assessment of the Upper Extremity

    Time frame: From baseline to end of therapy (3 weeks)

    We measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 3-week therapy (intervention 1) and 12-week post-stroke to end of 3-week therapy (Intervention 2). Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. For this study, we analyze total score only. The higher scores indicate a better outcome.

  2. Action Research Arm Test

    Time frame: From baseline to end of therapy (3 weeks)

    We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 3-week therapy (Intervention 1) and 12-week post-stroke to 3-week therapy (Intervention 2). The ARAT is a 57-point scale which measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome.

  3. 9-Hole Peg Test

    Time frame: From baseline to end of therapy (3 week)

    We compared the change in 9-Hole Peg Test scores from the baseline evaluation to 3-week therapy (Intervention 1) and 12-week post-stroke to 3-week therapy (Intervention 2). The 9-Hole Peg Test is a timed test that measures the time it takes to place, and remove 9 pegs. The maximum allowed time for the test is 60 seconds. The more number of pegs placed and removed indicate a better outcome. The shorter time it takes to complete the task indicates a better outcome.

Sponsors and collaborators

Lead sponsor

David Reinkensmeyer

Other

Registry information

Official study title

Influence of Timing on Motor Learning

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 7, 2015
Registry last updated
Oct 13, 2022

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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