Balance DisordersNCT06399224
Effect of Planter Vibration and Otago Exercise in Old Hemiplegic Patients
A study testing Local Plantar vibrator and Otago exercise in people with Balance Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to determine effect of Plantar vibration and Otago exercise on risk of fall and quality of life in hemiplegic elderly Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Balance Disorders
- What is being tested?
- Local Plantar vibrator and Otago exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2024to 10 Aug 2024
- 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 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- first-ever stroke
- age 65-75years
- duration since stroke ≥6 months
- balance deficit confirmed by one leg stance (OLS) test; patient unable to stand on affected leg for 30s with eyes open
- able to walk without the use of aids .able to understand verbal commands.
Who cannot join
- participation in other treatment protocols for balance
- presence of conditions other than stroke affecting balance
- history of lower-limb surgery within the previous year
- fixed ankle contractures
- cognitive impairments (MMSE<24)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Planter Vibration and Otago Exercise on Risk of Fall and Quality of Life in Hemiplegic Elderly
This study aims to determine effect of Plantar vibration and Otago exercise on risk of fall and quality of life in hemiplegic elderly
Read the detailed description
Stroke is one of the major causes of permanent disability. Stroke can have many causes and occurs mainly in old age, Hemiplegic patients have a two-fold higher risk of falling than other patients of the same age or gender, beside fall in older adults can cause significant physical and psychological injury to the individual. Otago exercises are the interventions given for fall prevention in elderly and showed good results with hemiplegic cases as well, it is easy and could be done by old adults even at home. Plantar vibration as a cheap, portable, and easy applicable, saving time and with no effort could be a good choice as a treatment tool to be added for old hemiplegic patients treatment programme. Thus applying an easy and effective programme for old hemiplegic subjects that reduces their risk of fall and improves their balance and ADL and at the same time helps them to conduct it easily and adhere to it should be our target to full fill.
- Conditions
- Balance Disorders
- Being tested
- Local Plantar vibrator, Otago exercise
- Keywords
- Hemiplegic elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Plantar vibratorDevice
Also called Vibrasens (Techno Concept, Loupian, France)
A vibrating device that applies 80 hz vibration waves applied on the sole of the foot
Otago exerciseOther
Warm up Front Knee strength Back knee strength Side hip strength Calf raising Toe raising Sit to stand Heel walk Toe walk One leg standing Side way walk Cool down
| Study group | Role | What they receive |
|---|---|---|
| Planter vibrator with otago exercise | Active comparator | This group will receive15 minutes of plantar vibration with frequency of 80 Hz, with 10 seconds of vibration and 5 seconds of rest with total time 15 min before the 50 minutes Otago exercise. The frequency of the exercise will be 3 times a week for 12 weeks. Receives: Device: Local Plantar vibrator; Other: Otago exercise |
| Otago exercise | Active comparator | This group will receive 50 minutes Otago exercise only. The frequency of the exercise will be 3 times a week for 12 weeks. Receives: Other: Otago exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: Through 12 weeks
Time up and go test
The participant was instructed to sit back in the chair without arms, to stand up on the command "Go," walk 3 m to the line marked on the floor at a normal pace, turn 180°, and walk back to the chair, and sit down again on the chair,An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Measured: Through 12 weeks
Secondary outcomes (3)
Stroke specific quality of life scale
It is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke.Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains.Higher scores indicate better functioning.
Measured: Through 12 weeks
Modified barthel index
It is composed of the following 10 items investigating 10 functional ADLs: feeding, personal hygiene, bathing, dressing, chair-bed transfer, toileting, bladder continence, bowel continence, ambulation or wheelchair use, and stair climbing. The score for each item is attributed by the clinician who observes the patient while performing the functional task and evaluates the amount of assistance the patient requires using a 5-point Likert scale.Each activity is assigned a score from 0 to 15, indicating the patient's level of independence.Higher scores signify greater independence, while lower scores indicate dependence or the need for assistance.
Measured: Though 12 weeks
Ankle PROM
The 90° was defined as the neutral position for the measurements using an ankle biplane goniometer Ankle dorsiflexion and plantarflexion from the neutral position was given either a positive or negative value
Measured: Though 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 May 2024
- Primary completion5 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Balance DisordersStudies 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
- Model description
- The study group will be treated with both plantar vibration and Otago exercise whereas the control group will receive Otago exercise only. Both groups will receive a 50 minutes of otago exercise program except for the study group will take 15 minutes of plantar vibration with frequency of 80 Hz, with 10 seconds of vibration and 5 seconds of rest with total time 15 min before the Otago exercise. The frequency of the exercise will be 3 times a week for 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Aziz Guirguis, Cairo University
- Investigators
- A.M Baky, Professor, Study director, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399224
- Sponsor's protocol ID
- Vibration on hemiplegia
- Status last verified
- Aug 2024
- First submitted
- 1 May 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
PubMed 29740561Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.
PubMed 36339194
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Planter Vibration and Otago Exercise on Risk of Fall and Quality of Life in Hemiplegic Elderly
- ClinicalTrials.gov ID
- NCT06399224
- Acronym / sponsor ID
- Vibration on hemiplegia
- Conditions
- Balance Disorders
- Keywords
- Hemiplegic elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 3 May 2024 (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.
This study aims to determine effect of Plantar vibration and Otago exercise on risk of fall and quality of life in hemiplegic elderly
Detailed description
Stroke is one of the major causes of permanent disability. Stroke can have many causes and occurs mainly in old age, Hemiplegic patients have a two-fold higher risk of falling than other patients of the same age or gender, beside fall in older adults can cause significant physical and psychological injury to the individual. Otago exercises are the interventions given for fall prevention in elderly and showed good results with hemiplegic cases as well, it is easy and could be done by old adults even at home. Plantar vibration as a cheap, portable, and easy applicable, saving time and with no effort could be a good choice as a treatment tool to be added for old hemiplegic patients treatment programme. Thus applying an easy and effective programme for old hemiplegic subjects that reduces their risk of fall and improves their balance and ADL and at the same time helps them to conduct it easily and adhere to it should be our target to full fill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study group will be treated with both plantar vibration and Otago exercise whereas the control group will receive Otago exercise only. Both groups will receive a 50 minutes of otago exercise program except for the study group will take 15 minutes of plantar vibration with frequency of 80 Hz, with 10 seconds of vibration and 5 seconds of rest with total time 15 min before the Otago exercise. The frequency of the exercise will be 3 times a week for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Planter vibrator with otago exercise | Active comparator | Device: Local Plantar vibrator, Other: Otago exerciseThis group will receive15 minutes of plantar vibration with frequency of 80 Hz, with 10 seconds of vibration and 5 seconds of rest with total time 15 min before the 50 minutes Otago exercise. The frequency of the exercise will be 3 times a week for 12 weeks. |
| Otago exercise | Active comparator | Other: Otago exerciseThis group will receive 50 minutes Otago exercise only. The frequency of the exercise will be 3 times a week for 12 weeks. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- first-ever stroke
- age 65-75years
- duration since stroke ≥6 months
- balance deficit confirmed by one leg stance (OLS) test; patient unable to stand on affected leg for 30s with eyes open
- able to walk without the use of aids .able to understand verbal commands.
Key exclusion criteria (5 listed)
- participation in other treatment protocols for balance
- presence of conditions other than stroke affecting balance
- history of lower-limb surgery within the previous year
- fixed ankle contractures
- cognitive impairments (MMSE<24)
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 |
|---|---|---|
| Local Plantar vibratorAlso: Vibrasens (Techno Concept, Loupian, France)A vibrating device that applies 80 hz vibration waves applied on the sole of the foot | Device | Planter vibrator with otago exercise |
| Otago exerciseWarm up Front Knee strength Back knee strength Side hip strength Calf raising Toe raising Sit to stand Heel walk Toe walk One leg standing Side way walk Cool down | Other | Otago exercise, Planter vibrator with otago exercise |
Primary outcome
Berg balance scale
Time frame: Through 12 weeks
It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Time up and go test
Time frame: Through 12 weeks
The participant was instructed to sit back in the chair without arms, to stand up on the command "Go," walk 3 m to the line marked on the floor at a normal pace, turn 180°, and walk back to the chair, and sit down again on the chair,An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
3 secondary outcomes
Stroke specific quality of life scale
Time frame: Through 12 weeks
Modified barthel index
Time frame: Though 12 weeks
Ankle PROM
Time frame: Though 12 weeks
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 21 Aug 2024.
- Background: PubMed 29740561Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Background: PubMed 36339194Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.
- 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.
A.M Baky, Professor study director
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Plantar vibrator and Otago exercise in people with Balance Disorders, 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 5 inclusion and 5 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 21 Aug 2024. 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?
Berg balance scale (time frame: Through 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06399224, which also lists 2 linked publications.
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 21 Aug 2024.