NCT04820777

Brief 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 control in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 26, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

StrokePerturbation based trainingFallBerg balance scalePerformance oriented mobility assessment

Outcome Measures

Primary Outcomes (3)

  • Tinetti performance oriented mobility assessment

    POMA for gait and balance for stroke patients

    2 months

  • Time up and go (TUG)

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

    2 months

  • 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

    2 months

Study Arms (2)

perturbation based training

EXPERIMENTAL

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,

Other: perturbation training

Conventional' balance training

ACTIVE COMPARATOR

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 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.

Other: Conventional' balance training

Interventions

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,

perturbation based training

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

Conventional' balance training

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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.

    PMID: 27633021BACKGROUND
  • 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.

    PMID: 27791207BACKGROUND
  • 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.

    PMID: 28597708BACKGROUND
  • 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.

    PMID: 27415645BACKGROUND
  • 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.

    PMID: 30916531BACKGROUND
  • 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.

    PMID: 30213258BACKGROUND
  • 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.

    PMID: 28687056BACKGROUND
  • 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.

    PMID: 29514677BACKGROUND
  • 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.

    PMID: 28503533BACKGROUND
  • 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.

    PMID: 30630753BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

March 29, 2021

Study Start

February 15, 2020

Primary Completion

October 20, 2020

Study Completion

December 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations