StrokeNCT05588661
PBBT and WBV Effect on Balance and Gait in Stroke
A study testing Perturbation Exercises and Whole Body Vibration in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effects of perturbation based balance exercises with whole body vibration training in sub-acute stroke patients and to evaluate their effects on balance, and gait. The main aim to : To evaluate their effects on balance, and gait. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Perturbation Exercises and Whole Body Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Apr 2022to 15 Nov 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed patient of ischemic stroke (12 week to 20 weeks).
- Male and female, (40-60 year).
- Able to maintain standing posture, 4-5 score on level of independence scale.
- Patients able to perform 2-meter walk test.
- Score less than 20-24/56 on berg balance scale.
Who cannot join
- Patients with other neurological disorders (Alzheimer's, Parkinson's vestibular impairments etc.)
- Any significant balance impairment on Berg Balance Scale.
- Orthopaedic Problems.
- Patients who can't perform 30 sec sit to stand.
- Patients with any trauma, and blindness.
- Lower extremity weight bearing pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Perturbation Based Balance Training and Whole Body Vibration on Balance and Gait in Sub-acute Stroke Patients.
The goal of this clinical trial is to compare the effects of perturbation based balance exercises with whole body vibration training in sub-acute stroke patients and to evaluate their effects on balance, and gait. The main aim to :
- To evaluate their effects on balance, and gait.
- Comparison of these rehabilitation protocols and identify the more efficacious treatment.
Participants will perform perturbation based balance training and whole body vibration therapy to improve balance and gait.
If there is a comparison group: Researchers will compare both groups to see both interventions effects.
Read the detailed description
Stroke usually causes impairments in a variety of areas, such as cognition, emotion, mobility limitation, sensory loss, and there after results in imbalance and gait disability as well as impairment of the activities of daily living (ADLs). Poor balance control have a negative influence on the recovery of gait and motor function. Many therapeutic interventions, such as visual feedback training, robotic devices, mirror therapy, and motor imagery training have been performed to improve balance control.
Reactive balance training (RBT) has emerged as a potential strategy for improving balance and participants withstood greater-magnitude perturbations before requiring multiple steps, relative to those who completed weight-shifting/gait training in sub-acute and chronic stroke patients.
Whole-body vibration (WBV) therapy used in clinical practice for improving neuro-motor performance in various patient populations and this training reduce disability by improving balance, gait performance, and mobility in stroke patients.
According to previous literature there was a lack of comparison of these two studies. In previous literature, both of these therapeutic options i.e., Perturbation based balance training (PBBT) and whole body vibration (WBV) training were used separately to see the effects in stroke population but not in combination. In this study the comparison will be done between these two exercise protocols. Consequences will be manipulated for balance, and gait by using validated tools.
- Conditions
- Stroke
- Being tested
- Perturbation Exercises, Whole Body Vibration
- Keywords
- Perturbation Exercises, Whole body vibration, Stroke, Balance, Gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation ExercisesOther
Perturbation exercises will be performed 3 times in a week for 6 weeks for 10-15 minutes per session with baseline treatment for total 30 minutes.
Total 18 sessions will be given to the patients.
Whole Body VibrationOther
It will be performed 3 times in a week for 10-15 minutes per session with baseline treatment for total 30 mints.
Total 18 sessions will be given for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Perturbation Exercises | Experimental | Perturbation Based Balance Training Receives: Other: Perturbation Exercises |
| Whole Body Vibration | Experimental | Whole Body Vibration Therapy Receives: Other: Whole Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Changes from baseline, BBS was designed to measure the static and dynamic balance in post stroke patients.It consist of 14 items which scores vary from 0-4. Maximum no. of score ranges from 0-56. A person with a score 0-20 range will likely need the assistance of a wheelchair to move around safely.
A person with a score 21 to 40 range will need some type of walking assistance, such as a cane or a walker.
41 to 56: A person with a score in this range is considered independent and should be able to move around safely without assistance.
Measured: 6th week
Dynamic Gait Index
Changes from baseline,The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.It includes eight items,each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment.
The best possible score on the DGI is a 24 as this is the total no. of score. If score is < 19/24 it indicates predictive of falls in the elderly, and score > 22/24 indicates the safe ambulators.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start4 Apr 2022
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588661
- Sponsor's protocol ID
- REC/RCR&AHS/22/0229
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park YJ, Park SW, Lee HS. Comparison of the Effectiveness of Whole Body Vibration in Stroke Patients: A Meta-Analysis. Biomed Res Int. 2018 Jan 2;2018:5083634. doi: 10.1155/2018/5083634. eCollection 2018.
PubMed 29487869Sparaco M, Ciolli L, Zini A. Posterior circulation ischaemic stroke-a review part I: anatomy, aetiology and clinical presentations. Neurol Sci. 2019 Oct;40(10):1995-2006. doi: 10.1007/s10072-019-03977-2. Epub 2019 Jun 20.
PubMed 31222544Schinkel-Ivy A, Huntley AH, Danells CJ, Inness EL, Mansfield A. Improvements in balance reaction impairments following reactive balance training in individuals with sub-acute stroke: A prospective cohort study with historical control. Top Stroke Rehabil. 2020 May;27(4):262-271. doi: 10.1080/10749357.2019.1690795. Epub 2019 Nov 19.
PubMed 31742486Hasan TF, Rabinstein AA, Middlebrooks EH, Haranhalli N, Silliman SL, Meschia JF, Tawk RG. Diagnosis and Management of Acute Ischemic Stroke. Mayo Clin Proc. 2018 Apr;93(4):523-538. doi: 10.1016/j.mayocp.2018.02.013.
PubMed 29622098Belas Dos Santos M, Barros de Oliveira C, Dos Santos A, Garabello Pires C, Dylewski V, Arida RM. A Comparative Study of Conventional Physiotherapy versus Robot-Assisted Gait Training Associated to Physiotherapy in Individuals with Ataxia after Stroke. Behav Neurol. 2018 Feb 20;2018:2892065. doi: 10.1155/2018/2892065. eCollection 2018.
PubMed 29675114Kim J, Kim DY, Chun MH, Kim SW, Jeon HR, Hwang CH, Choi JK, Bae S. Effects of robot-(Morning Walk(R)) assisted gait training for patients after stroke: a randomized controlled trial. Clin Rehabil. 2019 Mar;33(3):516-523. doi: 10.1177/0269215518806563. Epub 2018 Oct 16.
PubMed 30326747de Rooij IJM, van de Port IGL, Visser-Meily JMA, Meijer JG. Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial. Trials. 2019 Jan 29;20(1):89. doi: 10.1186/s13063-018-3165-7.
PubMed 30696491van Duijnhoven HJR, Roelofs JMB, den Boer JJ, Lem FC, Hofman R, van Bon GEA, Geurts ACH, Weerdesteyn V. Perturbation-Based Balance Training to Improve Step Quality in the Chronic Phase After Stroke: A Proof-of-Concept Study. Front Neurol. 2018 Nov 22;9:980. doi: 10.3389/fneur.2018.00980. eCollection 2018.
PubMed 30524360Kim JW, Lee JH. Effect of whole-body vibration therapy on lower extremity function in subacute stroke patients. J Exerc Rehabil. 2021 Jun 30;17(3):158-163. doi: 10.12965/jer.2142246.123. eCollection 2021 Jun.
PubMed 34285892Sade I, Cekmece C, Inanir M, SelCuk B, Dursun N, Dursun E. The Effect of Whole Body Vibration Treatment on Balance and Gait in Patients with Stroke. Noro Psikiyatr Ars. 2019 Aug 20;57(4):308-311. doi: 10.29399/npa.23380. eCollection 2020 Dec.
PubMed 33354124Gath CF, Gianella MG, Bonamico L, Olmos L, Russo MJ. Prediction of Balance After Inpatient Rehabilitation in Stroke Subjects with Severe Balance Alterations at the Admission. J Stroke Cerebrovasc Dis. 2021 Apr;30(4):105627. doi: 10.1016/j.jstrokecerebrovasdis.2021.105627. Epub 2021 Jan 25.
PubMed 33508725Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
PubMed 30476999
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Perturbation Based Balance Training and Whole Body Vibration on Balance and Gait in Sub-acute Stroke Patients.
- ClinicalTrials.gov ID
- NCT05588661
- Acronym / sponsor ID
- REC/RCR&AHS/22/0229
- Conditions
- Stroke
- Keywords
- Perturbation Exercises, Whole body vibration, Stroke, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 20 Oct 2022 (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 goal of this clinical trial is to compare the effects of perturbation based balance exercises with whole body vibration training in sub-acute stroke patients and to evaluate their effects on balance, and gait. The main aim to :
- To evaluate their effects on balance, and gait.
- Comparison of these rehabilitation protocols and identify the more efficacious treatment.
Participants will perform perturbation based balance training and whole body vibration therapy to improve balance and gait.
If there is a comparison group: Researchers will compare both groups to see both interventions effects.
Detailed description
Stroke usually causes impairments in a variety of areas, such as cognition, emotion, mobility limitation, sensory loss, and there after results in imbalance and gait disability as well as impairment of the activities of daily living (ADLs). Poor balance control have a negative influence on the recovery of gait and motor function. Many therapeutic interventions, such as visual feedback training, robotic devices, mirror therapy, and motor imagery training have been performed to improve balance control.
Reactive balance training (RBT) has emerged as a potential strategy for improving balance and participants withstood greater-magnitude perturbations before requiring multiple steps, relative to those who completed weight-shifting/gait training in sub-acute and chronic stroke patients.
Whole-body vibration (WBV) therapy used in clinical practice for improving neuro-motor performance in various patient populations and this training reduce disability by improving balance, gait performance, and mobility in stroke patients.
According to previous literature there was a lack of comparison of these two studies. In previous literature, both of these therapeutic options i.e., Perturbation based balance training (PBBT) and whole body vibration (WBV) training were used separately to see the effects in stroke population but not in combination. In this study the comparison will be done between these two exercise protocols. Consequences will be manipulated for balance, and gait by using validated tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation Exercises | Experimental | Other: Perturbation ExercisesPerturbation Based Balance Training |
| Whole Body Vibration | Experimental | Other: Whole Body VibrationWhole Body Vibration Therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed patient of ischemic stroke (12 week to 20 weeks).
- Male and female, (40-60 year).
- Able to maintain standing posture, 4-5 score on level of independence scale.
- Patients able to perform 2-meter walk test.
- Score less than 20-24/56 on berg balance scale.
Key exclusion criteria (6 listed)
- Patients with other neurological disorders (Alzheimer's, Parkinson's vestibular impairments etc.)
- Any significant balance impairment on Berg Balance Scale.
- Orthopaedic Problems.
- Patients who can't perform 30 sec sit to stand.
- Patients with any trauma, and blindness.
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 |
|---|---|---|
| Perturbation ExercisesPerturbation exercises will be performed 3 times in a week for 6 weeks for 10-15 minutes per session with baseline treatment for total 30 minutes. Total 18 sessions will be given to the patients. | Other | Perturbation Exercises |
| Whole Body VibrationIt will be performed 3 times in a week for 10-15 minutes per session with baseline treatment for total 30 mints. Total 18 sessions will be given for 6 weeks | Other | Whole Body Vibration |
Primary outcome
Berg Balance Scale
Time frame: 6th week
Changes from baseline, BBS was designed to measure the static and dynamic balance in post stroke patients.It consist of 14 items which scores vary from 0-4. Maximum no. of score ranges from 0-56. A person with a score 0-20 range will likely need the assistance of a wheelchair to move around safely. A person with a score 21 to 40 range will need some type of walking assistance, such as a cane or a walker. 41 to 56: A person with a score in this range is considered independent and should be able to move around safely without assistance.
Dynamic Gait Index
Time frame: 6th week
Changes from baseline,The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk.It includes eight items,each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24 as this is the total no. of score. If score is < 19/24 it indicates predictive of falls in the elderly, and score > 22/24 indicates the safe ambulators.
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 30 Jan 2024.
- Background: PubMed 29487869Park YJ, Park SW, Lee HS. Comparison of the Effectiveness of Whole Body Vibration in Stroke Patients: A Meta-Analysis. Biomed Res Int. 2018 Jan 2;2018:5083634. doi: 10.1155/2018/5083634. eCollection 2018.
- Background: PubMed 31222544Sparaco M, Ciolli L, Zini A. Posterior circulation ischaemic stroke-a review part I: anatomy, aetiology and clinical presentations. Neurol Sci. 2019 Oct;40(10):1995-2006. doi: 10.1007/s10072-019-03977-2. Epub 2019 Jun 20.
- Background: PubMed 31742486Schinkel-Ivy A, Huntley AH, Danells CJ, Inness EL, Mansfield A. Improvements in balance reaction impairments following reactive balance training in individuals with sub-acute stroke: A prospective cohort study with historical control. Top Stroke Rehabil. 2020 May;27(4):262-271. doi: 10.1080/10749357.2019.1690795. Epub 2019 Nov 19.
- Background: PubMed 29622098Hasan TF, Rabinstein AA, Middlebrooks EH, Haranhalli N, Silliman SL, Meschia JF, Tawk RG. Diagnosis and Management of Acute Ischemic Stroke. Mayo Clin Proc. 2018 Apr;93(4):523-538. doi: 10.1016/j.mayocp.2018.02.013.
- Background: PubMed 29675114Belas Dos Santos M, Barros de Oliveira C, Dos Santos A, Garabello Pires C, Dylewski V, Arida RM. A Comparative Study of Conventional Physiotherapy versus Robot-Assisted Gait Training Associated to Physiotherapy in Individuals with Ataxia after Stroke. Behav Neurol. 2018 Feb 20;2018:2892065. doi: 10.1155/2018/2892065. eCollection 2018.
- Background: PubMed 30326747Kim J, Kim DY, Chun MH, Kim SW, Jeon HR, Hwang CH, Choi JK, Bae S. Effects of robot-(Morning Walk(R)) assisted gait training for patients after stroke: a randomized controlled trial. Clin Rehabil. 2019 Mar;33(3):516-523. doi: 10.1177/0269215518806563. Epub 2018 Oct 16.
- Background: PubMed 30696491de Rooij IJM, van de Port IGL, Visser-Meily JMA, Meijer JG. Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial. Trials. 2019 Jan 29;20(1):89. doi: 10.1186/s13063-018-3165-7.
- Background: PubMed 30524360van Duijnhoven HJR, Roelofs JMB, den Boer JJ, Lem FC, Hofman R, van Bon GEA, Geurts ACH, Weerdesteyn V. Perturbation-Based Balance Training to Improve Step Quality in the Chronic Phase After Stroke: A Proof-of-Concept Study. Front Neurol. 2018 Nov 22;9:980. doi: 10.3389/fneur.2018.00980. eCollection 2018.
- Background: PubMed 34285892Kim JW, Lee JH. Effect of whole-body vibration therapy on lower extremity function in subacute stroke patients. J Exerc Rehabil. 2021 Jun 30;17(3):158-163. doi: 10.12965/jer.2142246.123. eCollection 2021 Jun.
- Background: PubMed 33354124Sade I, Cekmece C, Inanir M, SelCuk B, Dursun N, Dursun E. The Effect of Whole Body Vibration Treatment on Balance and Gait in Patients with Stroke. Noro Psikiyatr Ars. 2019 Aug 20;57(4):308-311. doi: 10.29399/npa.23380. eCollection 2020 Dec.
- Background: PubMed 33508725Gath CF, Gianella MG, Bonamico L, Olmos L, Russo MJ. Prediction of Balance After Inpatient Rehabilitation in Stroke Subjects with Severe Balance Alterations at the Admission. J Stroke Cerebrovasc Dis. 2021 Apr;30(4):105627. doi: 10.1016/j.jstrokecerebrovasdis.2021.105627. Epub 2021 Jan 25.
- Background: PubMed 30476999Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639.
- 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.
Binash Afzal, Phd* principal investigator
Riphah International 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 Perturbation Exercises and Whole Body Vibration in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 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 30 Jan 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 Pakistan. 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: 6th week). 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 NCT05588661, which also lists 12 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 30 Jan 2024.