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

Cerebrovascular Accident Clinical Trial

Official title:

Influence of Timing on Motor Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410629
• Other study ID #: IRB# 2008-6432
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• Music Glove
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.

Other:
• Conventional Hand Exercise Program
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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
David Reinkensmeyer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Block Test	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.	From baseline to end of therapy (3 weeks)
Secondary	Fugl-Meyer Motor Assessment of the Upper Extremity	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.	From baseline to end of therapy (3 weeks)
Secondary	Action Research Arm Test	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.	From baseline to end of therapy (3 weeks)
Secondary	9-Hole Peg Test	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.	From baseline to end of therapy (3 week)