AzTrials
AzTrials

StrokeNCT04820777

Effects Of Perturbation Based Balance Training in Reactive Balance Control Among Chronic Stroke Patients

A study testing perturbation training and Conventional' balance training in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic stroke patients often have impaired balance on reactive balance control. Task specific exercises are important part of the fall intervention in daily activities of life should be incorporated during the rehabilitative services Objective: Effects of perturbation based balance training in reactive balance… Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Stroke
What is being tested?
perturbation training and Conventional' balance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 sitePakistan
Study dates
15 Feb 2020to 30 Dec 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who was not obese and BMI was <28
  • Individuals at chronic stroke level (>6 months post stroke).
  • The patients who can walk with or without a gait aid (but without assistance of another

Who cannot join

  • • Different neurological diseases and problems that can impaired balance control (e.g. Parkinson's disease); upper or the lower body parts amputation; cognitive, language, or social impairments which can affect the following of instructions.
  • Patients who were attending any perturbation based training
  • Patients who were visually impaired, having orthostatic hypotension or dizziness

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Binash afzal

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Chronic stroke patients often have impaired balance on reactive balance control. Task specific exercises are important part of the fall intervention in daily activities of life should be incorporated during the rehabilitative services Objective: Effects of perturbation based balance training in reactive balance control in chronic stroke patients.

Read the detailed description

RCT (Randomized Control Trail) study was conducted. Stroke patients who have impaired balance and reactive control were determined on inclusion \& exclusion criteria. Stroke patients with impaired balance control were arbitrarily allocated into two groups with one control and one interventional group ages ranged from 45 to 50 years. The sample size was 20 patients. Group 1 (control group) received tradional balance training and Group 2 (interventional group) received perturbation based training for balance control. The interval of treatment was 6 weeks. Data is collected from Azra Naheed Medical college (Ch Muhammad Akram teaching \& research hospital) Lahore and Physiotherapy department of Social security hospital manga mandi Lahore. Tinetti performance oriented mobility assessment (POMA),Time up and go (TUG) and Activity specific balance confidence (ABC) was used to evaluate the pre and post values of balance control.

Conditions
Stroke
Being tested
perturbation training, Conventional' balance training
Keywords
Stroke, Perturbation based training, Fall, Berg balance scale, Performance oriented mobility assessment
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • perturbation trainingOther

    external or internal postural perturbations. External perturbations occur by forces outside the patient' control (e.g., a push or pull from the physiotherapist). Internal perturbations caused when the patient is unable to control the centre of mass and the base of support relationship during voluntary movement; 'agility' tasks, such as kicking a soccer ball,

  • Conventional' balance trainingOther

    Starting from a situated position, expand your left leg until it's corresponding to the floor. Try not to bolt your knee. At that point, gradually bring your foot down to the floor. Rehash with your correct leg, exchanging to and fro between legs for a s

Study groups in NCT04820777
Study groupRoleWhat they receive
perturbation based trainingExperimentalExternal perturbations occur by forces outside the patient' control (e.g., a push or pull from the physiotherapist). Internal perturbations caused when the patient is unable to control the centre of mass and the base of support relationship during voluntary movement; 'agility' tasks, such as kicking a soccer ball,
Receives: Other: perturbation training
Conventional' balance trainingActive comparatorStarting from a situated position, expand your left leg until it's corresponding to the floor. Try not to bolt your knee. At that point, gradually bring your foot down to the floor. Rehash with your correct leg, exchanging to and fro between legs for a sum of 20 repitions (10 on every leg). Situated Marching Starting with a situated position, lift your effected leg towards your chest, making an honest effort to keep up controlled development.
Receives: Other: Conventional' balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinetti performance oriented mobility assessment

    POMA for gait and balance for stroke patients

    Measured: 2 months

  2. Time up and go (TUG)

    screening test that is a sensitive and specific measure of probability for falls among older adults[

    Measured: 2 months

  3. Activity specific balance confidence (ABC)

    the Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual's confidence in performing activities without losing balance

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start15 Feb 2020
  3. Primary completion20 Oct 2020
  4. Study completion30 Dec 2020

Resources

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
Single blind
Who is masked
Participant
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04820777
Sponsor's protocol ID
REC/Lhr/20/2049 Hira Irfan
Status last verified
Mar 2021
First submitted
26 Mar 2021
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Duijnhoven HJ, Heeren A, Peters MA, Veerbeek JM, Kwakkel G, Geurts AC, Weerdesteyn V. Effects of Exercise Therapy on Balance Capacity in Chronic Stroke: Systematic Review and Meta-Analysis. Stroke. 2016 Oct;47(10):2603-10. doi: 10.1161/STROKEAHA.116.013839. Epub 2016 Sep 15.

    PubMed 27633021

  • In T, Lee K, Song C. Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with Chronic Stroke: Randomized Controlled Trials. Med Sci Monit. 2016 Oct 28;22:4046-4053. doi: 10.12659/msm.898157.

    PubMed 27791207

  • Lund C, Dalgas U, Gronborg TK, Andersen H, Severinsen K, Riemenschneider M, Overgaard K. Balance and walking performance are improved after resistance and aerobic training in persons with chronic stroke. Disabil Rehabil. 2018 Oct;40(20):2408-2415. doi: 10.1080/09638288.2017.1336646. Epub 2017 Jun 9.

    PubMed 28597708

  • Vahlberg B, Cederholm T, Lindmark B, Zetterberg L, Hellstrom K. Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial. Disabil Rehabil. 2017 Aug;39(16):1615-1622. doi: 10.1080/09638288.2016.1206631. Epub 2016 Jul 14.

    PubMed 27415645

  • Lee D, Lee G. Effect of afferent electrical stimulation with mirror therapy on motor function, balance, and gait in chronic stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Aug;55(4):442-449. doi: 10.23736/S1973-9087.19.05334-6. Epub 2019 Mar 22.

    PubMed 30916531

  • Alghadir AH, Al-Eisa ES, Anwer S, Sarkar B. Reliability, validity, and responsiveness of three scales for measuring balance in patients with chronic stroke. BMC Neurol. 2018 Sep 13;18(1):141. doi: 10.1186/s12883-018-1146-9.

    PubMed 30213258

  • Tally Z, Boetefuer L, Kauk C, Perez G, Schrand L, Hoder J. The efficacy of treadmill training on balance dysfunction in individuals with chronic stroke: a systematic review. Top Stroke Rehabil. 2017 Oct;24(7):539-546. doi: 10.1080/10749357.2017.1345445. Epub 2017 Jul 7.

    PubMed 28687056

  • Liu TW, Ng GYF, Ng SSM. Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):168. doi: 10.1186/s13063-018-2549-z.

    PubMed 29514677

  • Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.

    PubMed 28503533

  • Schinkel-Ivy A, Huntley AH, Aqui A, Mansfield A. Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? J Stroke Cerebrovasc Dis. 2019 Apr;28(4):935-943. doi: 10.1016/j.jstrokecerebrovasdis.2018.12.011. Epub 2019 Jan 7.

    PubMed 30630753

Questions about this trial

What is this clinical trial studying?

A study testing perturbation training and Conventional' balance training 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 3 inclusion and 3 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 Mar 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 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?

Tinetti performance oriented mobility assessment (time frame: 2 months). 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?

On the ClinicalTrials.gov record for NCT04820777, which also lists 10 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 Mar 2021.

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