NCT04557839

Brief Summary

The aim of this study was to find out the role of balance training on vestibular function and proprioception feedback in stroke patients. It was a randomized control trial and was conducted in civil hospital Gujranwala. Current study was completed within the time duration of 6 month. Sample size of twenty four patient consists of both male and female aged between 50 years to 75 years. Each group contain 12 patient .Group A was experimental group which received balance exercise in two phases and group B (n=12) was control group received conventional therapy. Each of exercise program begun with 10 mints warm up consisting of walking ad light stretching of hip flexor. The balance training group received the balance training exercise twice a week for 6 week each session comprise of 60 minutes. Each set consisted of 4 periods of 11 exercises and rest of 40 seconds. Many exercises over time was turned into circuit training. Data was analyzed by using SPSS version 23.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

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 20, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 16, 2020

Last Update Submit

September 16, 2020

Conditions

Keywords

Balance trainingStrokeProprioceptive feedbackVestibular function

Outcome Measures

Primary Outcomes (2)

  • Fukuda stepping test

    Changes from the baseline, It is neurological test to test vestibular function. Patient was asked to take 50 steps withy eyes closed in circle. After 50nsteps angle and distance measured from the initial to terminal position.

    6 week

  • Berg Balance Scale

    Changes from the baseline, The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. A score of 56 indicates functional balance.A score of \< 45 indicates individuals may be at greater risk of falling

    6 week

Study Arms (2)

Traditional physical therapy balance exercise

ACTIVE COMPARATOR

Traditional physical therapy including balance exercise on mate and swiss ball.

Other: Traditional physical therapy balance exercise

proprioception based balance training

EXPERIMENTAL

proprioception based balance training with eye open and close on soft , firm and foam surface.

Other: proprioception based balance training

Interventions

first phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward • Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training

Traditional physical therapy balance exercise

first phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward all exercise done under following condition. * eyes open firm surfaces * Eyes open soft surfaces * Eyes closed firm surfaces * Eyes closed soft surfaces (the soft surfaces will be a foam mate with 2.5 cm thick ) * These exercise will perform with turning the head side to side ad up and down * Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training

proprioception based balance training

Eligibility Criteria

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

You may qualify if:

  • Participants with impaired balance ,vestibular function and proprioception due to stroke
  • Victim of a stroke that resulted in hemiparesis,
  • Be at least 6 months
  • Be fully discharged from all rehabilitation program

You may not qualify if:

  • Those with recurrent strokes
  • Bilateral hemispheric cerebellar or brain stem lesions
  • Severe spasticity or cognitive deficit
  • Orthopedic or peripheral neuropathy
  • Significant visual field or hemi neglect problems were excluded.
  • They were medically unstable as determined by examination, history, or medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Civil hospital

Lahore, 54000, Pakistan

Location

Related Publications (15)

  • Pimentel BN, Filha VAVDS. Evaluation of vestibular and oculomotor functions in individuals with dizziness after stroke. Arq Neuropsiquiatr. 2019 Jan;77(1):25-32. doi: 10.1590/0004-282X20180154.

    PMID: 30758439BACKGROUND
  • Wiesmeier IK, Dalin D, Wehrle A, Granacher U, Muehlbauer T, Dietterle J, Weiller C, Gollhofer A, Maurer C. Balance Training Enhances Vestibular Function and Reduces Overactive Proprioceptive Feedback in Elderly. Front Aging Neurosci. 2017 Aug 11;9:273. doi: 10.3389/fnagi.2017.00273. eCollection 2017.

    PMID: 28848430BACKGROUND
  • Corriveau H, Hebert R, Raiche M, Prince F. Evaluation of postural stability in the elderly with stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1095-101. doi: 10.1016/j.apmr.2003.09.023.

    PMID: 15241756BACKGROUND
  • Barclay-Goddard R, Stevenson T, Poluha W, Moffatt ME, Taback SP. Force platform feedback for standing balance training after stroke. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004129. doi: 10.1002/14651858.CD004129.pub2.

    PMID: 15495079BACKGROUND
  • Yavuzer G, Eser F, Karakus D, Karaoglan B, Stam HJ. The effects of balance training on gait late after stroke: a randomized controlled trial. Clin Rehabil. 2006 Nov;20(11):960-9. doi: 10.1177/0269215506070315.

    PMID: 17065539BACKGROUND
  • Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26.

    PMID: 26157240BACKGROUND
  • Lubetzky-Vilnai A, Kartin D. The effect of balance training on balance performance in individuals poststroke: a systematic review. J Neurol Phys Ther. 2010 Sep;34(3):127-37. doi: 10.1097/NPT.0b013e3181ef764d.

    PMID: 20716987BACKGROUND
  • Tramontano M, Bergamini E, Iosa M, Belluscio V, Vannozzi G, Morone G. Vestibular rehabilitation training in patients with subacute stroke: A preliminary randomized controlled trial. NeuroRehabilitation. 2018;43(2):247-254. doi: 10.3233/NRE-182427.

    PMID: 30040765BACKGROUND
  • Cho S, Ku J, Cho YK, Kim IY, Kang YJ, Jang DP, Kim SI. Development of virtual reality proprioceptive rehabilitation system for stroke patients. Comput Methods Programs Biomed. 2014;113(1):258-65. doi: 10.1016/j.cmpb.2013.09.006. Epub 2013 Sep 19.

    PMID: 24183070BACKGROUND
  • Cha JH, Kim NH, Cha YJ. Effect of proprioceptive stimulation induced by footplate during center of pressure movement tracking training on the balance abilities of patients with chronic hemiplegic stroke: a randomized, controlled, pilot study. Top Stroke Rehabil. 2020 Jan;27(1):38-43. doi: 10.1080/10749357.2019.1661699. Epub 2019 Sep 4.

    PMID: 31480897BACKGROUND
  • Smania N, Picelli A, Gandolfi M, Fiaschi A, Tinazzi M. Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Neurol Sci. 2008 Oct;29(5):313-9. doi: 10.1007/s10072-008-0988-0. Epub 2008 Oct 21.

    PMID: 18941933BACKGROUND
  • Mao Y, Chen P, Li L, Huang D. Virtual reality training improves balance function. Neural Regen Res. 2014 Sep 1;9(17):1628-34. doi: 10.4103/1673-5374.141795.

    PMID: 25368651BACKGROUND
  • Walker C, Brouwer BJ, Culham EG. Use of visual feedback in retraining balance following acute stroke. Phys Ther. 2000 Sep;80(9):886-95.

    PMID: 10960936BACKGROUND
  • Chen IC, Cheng PT, Chen CL, Chen SC, Chung CY, Yeh TH. Effects of balance training on hemiplegic stroke patients. Chang Gung Med J. 2002 Sep;25(9):583-90.

    PMID: 12479619BACKGROUND
  • Donath L, Roth R, Zahner L, Faude O. Slackline Training (Balancing Over Narrow Nylon Ribbons) and Balance Performance: A Meta-Analytical Review. Sports Med. 2017 Jun;47(6):1075-1086. doi: 10.1007/s40279-016-0631-9.

    PMID: 27704483BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Binash Afzal, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

February 20, 2020

Primary Completion

August 20, 2020

Study Completion

September 15, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations