Hemiplegia, SpasticNCT04939493
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
A study testing Rhythmic Auditory Cueing, Bilateral arm training and Conventional physical therapy program in people with Hemiplegia, Spastic, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Hemiplegia, Spastic
- What is being tested?
- Rhythmic Auditory Cueing, Bilateral arm training and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic - Faculty of Physical Therapy - Cairo University
Dokki
About this study
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.
Read the 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.
- Conditions
- Hemiplegia, Spastic
- Being tested
- Rhythmic Auditory Cueing, Bilateral arm training, Conventional physical therapy program
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Auditory CueingOther
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 trainingOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic Auditory Cueing | Experimental | 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. Receives: Other: Rhythmic Auditory Cueing; Other: Bilateral arm training; Other: Conventional physical therapy program |
| Bilateral arm training | Active comparator | Patients in this group will receive a standard physical therapy program in addition to Bilateral arm training. Receives: Other: Bilateral arm training; Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 6 weeks post-intervention
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.
Measured: Baseline and 6 weeks post-intervention
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
Measured: Baseline and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jan 2021
- Primary completion30 May 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia, SpasticStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Hesham Mohamed Abdelhady, Cairo University
- Investigators
- Reem Abdelhady, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939493
- Sponsor's protocol ID
- Reem_MSc
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients
- ClinicalTrials.gov ID
- NCT04939493
- Acronym / sponsor ID
- Reem_MSc
- Conditions
- Hemiplegia, Spastic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Auditory Cueing | Experimental | Other: Rhythmic Auditory Cueing, Other: Bilateral arm training, Other: Conventional physical therapy programGroup (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. |
| Bilateral arm training | Active comparator | Other: Bilateral arm training, Other: Conventional physical therapy programPatients in this group will receive a standard physical therapy program in addition to Bilateral arm training. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- The patients will be excluded if they have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic Auditory CueingPatients 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%. | Other | Rhythmic Auditory Cueing |
| Bilateral arm trainingTraining 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 | Other | Bilateral arm training, Rhythmic Auditory Cueing |
| Conventional physical therapy programScapular 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. | Other | Bilateral arm training, Rhythmic Auditory Cueing |
Primary outcome
Assessing the change in Upper Extremity Motor Performance
Time frame: Baseline and 6 weeks post-intervention
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
Time frame: Baseline and 6 weeks post-intervention
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
Time frame: Baseline and 6 weeks post-intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Abdelhady principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Auditory Cueing, Bilateral arm training and Conventional physical therapy program in people with Hemiplegia, Spastic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in Upper Extremity Motor Performance (time frame: Baseline and 6 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.