Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients

NCT ID: NCT04939493

Last Updated: 2021-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-15

Brief Summary

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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

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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.

Conditions

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Hemiplegia, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Rhythmic Auditory Cueing

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.

Group Type EXPERIMENTAL

Rhythmic Auditory Cueing

Intervention Type OTHER

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%.

Bilateral arm training

Intervention Type OTHER

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

Conventional physical therapy program

Intervention Type OTHER

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.

Bilateral arm training

Patients in this group will receive a standard physical therapy program in addition to Bilateral arm training.

Group Type ACTIVE_COMPARATOR

Bilateral arm training

Intervention Type OTHER

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

Conventional physical therapy program

Intervention Type OTHER

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.

Interventions

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Rhythmic Auditory Cueing

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

Bilateral arm training

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

Conventional physical therapy program

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Thirty patients with ischemic stroke from both sexes will be included.
2. Patients will have stroke for the first time.
3. The age of patients will range from 45 to 60 years.
4. Duration of illness will be from six months to eighteen months.
5. The degree of spasticity will ranged from 1 to 1 + grade according to the modified Ashworth scale.
6. Patients will have moderate arm motor impairment (between 30 and 49 scores) according to Fugl-Meyer (FM) arm section scale.
7. The affected upper extremity will be the dominant side.
8. Patients will be able to sit and maintain balance in a sitting position.

Exclusion Criteria

* The patients will be excluded if they have:

1. Visual or auditory deficits.
2. Perceptual disorders.
3. Any surgical interventions in the upper extremities limiting the range of motion.
4. Aphasia or apraxia.
5. Musculoskeletal or neurological impairment of the unaffected upper extremity.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reem Hesham Mohamed Abdelhady

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reem Abdelhady

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Reem_MSc

Identifier Type: -

Identifier Source: org_study_id

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