Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
Primary Purpose
Hemiplegia, Spastic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rhythmic Auditory Cueing
Bilateral arm training
Conventional physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia, Spastic
Eligibility Criteria
Inclusion Criteria:
- Thirty patients with ischemic stroke from both sexes will be included.
- Patients will have stroke for the first time.
- The age of patients will range from 45 to 60 years.
- Duration of illness will be from six months to eighteen months.
- The degree of spasticity will ranged from 1 to 1 + grade according to the modified Ashworth scale.
- Patients will have moderate arm motor impairment (between 30 and 49 scores) according to Fugl-Meyer (FM) arm section scale.
- The affected upper extremity will be the dominant side.
- Patients will be able to sit and maintain balance in a sitting position.
Exclusion Criteria:
The patients will be excluded if they have:
- Visual or auditory deficits.
- Perceptual disorders.
- Any surgical interventions in the upper extremities limiting the range of motion.
- Aphasia or apraxia.
- Musculoskeletal or neurological impairment of the unaffected upper extremity.
Sites / Locations
- Outpatient clinic - Faculty of Physical Therapy - Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rhythmic Auditory Cueing
Bilateral arm training
Arm Description
Group (B): Patients in this group will receive the same designed physical therapy program given to the control group in addition to auditory cueing during bilateral arm training using the metronome.
Patients in this group will receive a standard physical therapy program in addition to Bilateral arm training.
Outcomes
Primary Outcome Measures
Assessing the change in Upper Extremity Motor Performance
Assessment via using Upper Extremity Motor Performance scale. This scale has been shown to be valid and reliable, and it correlates well with inter joint upper extremity coordination. It has a maximum score of 66
Assessing the change in upper limb Motor Function
Assessment via using Wolf Motor Function Test (WMFT) The final time score will be the median time required for all timed tasks executed. One hundred twenty seconds is the maximum time allowed for each task attempted Timing is carried out using a stopwatch.
Assessing the change in gross manual dexterity
Assessment via using Box and Block Test Involves moving 1-inch cube blocks from a rectangular box container to another container, and the number of blocks moved by each hand in 60 seconds is determined using stop watch
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04939493
Brief Title
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
Official Title
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine the effect of rhythmic auditory cueing with bilateral arm training on upper limb functions in stroke patients.
Detailed Description
Arm and hand movement problems are major contributors to disability in patients after stroke. In fact, only 5% of adults regain full arm function after stroke, and 20% regain no functional use. Hence, alternative strategies are needed to reduce the long-term disability and functional impairment from upper limb hemiparesis.
To solve problems concerning upper limb dysfunction related to stroke, various treatment methods have been used in several previous studies. Rhythmic auditory stimulation has been reported as an effective intervention for improving movement in the affected extremities of stroke patients.
To the best of our knowledge, no mentioned previous studies evaluating the effect of rhythmic auditory cueing with bilateral arm training using functional exercises on upper extremity impairment in patients with stroke in Egypt are reported. So, this study aims to determine the effect of rhythmic auditory cueing with bilateral arm training on upper limb functions in patients with stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Spastic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rhythmic Auditory Cueing
Arm Type
Experimental
Arm Description
Group (B): Patients in this group will receive the same designed physical therapy program given to the control group in addition to auditory cueing during bilateral arm training using the metronome.
Arm Title
Bilateral arm training
Arm Type
Active Comparator
Arm Description
Patients in this group will receive a standard physical therapy program in addition to Bilateral arm training.
Intervention Type
Other
Intervention Name(s)
Rhythmic Auditory Cueing
Intervention Description
Patients will perform the same movement sequence in time with the metronome beat. The frequency of the rhythmic auditory stimulation will be matched to the participant"s preferred movement speed, which will be assessed prior to the start of the trial, and participants typically started moving after they had heard the metronome beat two to three times. Participants will be given sufficient practice trials to ensure full understanding before the actual recording of data, and will be given 3-minutes break between trials.
On the 3rd and 5th week, the rhythm frequency was increased by 5%.
Intervention Type
Other
Intervention Name(s)
Bilateral arm training
Intervention Description
Training will consist of 20 minutes of bilateral arm training In each session, patients will be seated comfortably at a table in the following limb positions: ankles in neutral dorsiflexion, knees and hips placed at 90°, shoulders in 0° flexion, elbows in 60° flexion, and wrists in neutral position of flexion/extension
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy program
Intervention Description
Scapular mobilization. Thoracic spine mobilization. Mechanical assisted (active and passive) exercises. Therapeutic positioning as weight bearing on the paretic arm. Opening and closing closed fist. Strengthening exercise. Stretching of spastic muscles.
Primary Outcome Measure Information:
Title
Assessing the change in Upper Extremity Motor Performance
Description
Assessment via using Upper Extremity Motor Performance scale. This scale has been shown to be valid and reliable, and it correlates well with inter joint upper extremity coordination. It has a maximum score of 66
Time Frame
Baseline and 6 weeks post-intervention
Title
Assessing the change in upper limb Motor Function
Description
Assessment via using Wolf Motor Function Test (WMFT) The final time score will be the median time required for all timed tasks executed. One hundred twenty seconds is the maximum time allowed for each task attempted Timing is carried out using a stopwatch.
Time Frame
Baseline and 6 weeks post-intervention
Title
Assessing the change in gross manual dexterity
Description
Assessment via using Box and Block Test Involves moving 1-inch cube blocks from a rectangular box container to another container, and the number of blocks moved by each hand in 60 seconds is determined using stop watch
Time Frame
Baseline and 6 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thirty patients with ischemic stroke from both sexes will be included.
Patients will have stroke for the first time.
The age of patients will range from 45 to 60 years.
Duration of illness will be from six months to eighteen months.
The degree of spasticity will ranged from 1 to 1 + grade according to the modified Ashworth scale.
Patients will have moderate arm motor impairment (between 30 and 49 scores) according to Fugl-Meyer (FM) arm section scale.
The affected upper extremity will be the dominant side.
Patients will be able to sit and maintain balance in a sitting position.
Exclusion Criteria:
The patients will be excluded if they have:
Visual or auditory deficits.
Perceptual disorders.
Any surgical interventions in the upper extremities limiting the range of motion.
Aphasia or apraxia.
Musculoskeletal or neurological impairment of the unaffected upper extremity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem Abdelhady
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic - Faculty of Physical Therapy - Cairo University
City
Dokki
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
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