NCT05043727

Brief Summary

To compare the effects of exer-gaming with conventional physiotherapy on balance and gait in Parkinson's patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable parkinson-disease

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

October 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

August 27, 2021

Last Update Submit

September 13, 2021

Conditions

Keywords

Postural instability,Parkinson Disease,Exer Game

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's diseaserating scale (UPDRS)

    this test is specifically used in Parkinson patients to check balance

    50 minutes

Secondary Outcomes (1)

  • dynamic gait index.

    50 minutes

Study Arms (2)

Exer gaming treatment plan

EXPERIMENTAL

Exer gaming treatment plan

Combination Product: Exer gaming

conventional treatment plan

ACTIVE COMPARATOR

conventional treatment plan

Combination Product: conventional treatment plan

Interventions

Exer gamingCOMBINATION_PRODUCT

exer gaming treatment plan will include perfect ten balance, wii skiing, wiicycling. Each Patient will receive twenty four sessions. Each treatment session was of 50 minutes with two minutes rest between each exercise.

Exer gaming treatment plan
conventional treatment planCOMBINATION_PRODUCT

it will receive conventional treatment plan which includes balance training, gait training, stretching and strengthening exercises.Each patient will receive twenty four sessions of conventional physical therapy. Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.

conventional treatment plan

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed Parkinson's disease patients in stage I, II,III according to Hoeh n-Yahr classification.
  • Patients with balance and gait disorders

You may not qualify if:

  • Other neurological conditions (stroke, Alzheimer)
  • Red flag signs (tumors, fractures, infections etc)
  • Uncontrolled hypertension.
  • Patients with visual disturbances
  • Patients with cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

  • Liao YY, Yang YR, Cheng SJ, Wu YR, Fuh JL, Wang RY. Virtual Reality-Based Training to Improve Obstacle-Crossing Performance and Dynamic Balance in Patients With Parkinson's Disease. Neurorehabil Neural Repair. 2015 Aug;29(7):658-67. doi: 10.1177/1545968314562111. Epub 2014 Dec 24.

    PMID: 25539782BACKGROUND
  • Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

    PMID: 19025984BACKGROUND
  • Lee RG, Tonolli I, Viallet F, Aurenty R, Massion J. Preparatory postural adjustments in parkinsonian patients with postural instability. Can J Neurol Sci. 1995 May;22(2):126-35. doi: 10.1017/s0317167100040208.

    PMID: 7627914BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • zeest hashmi, MS NMPT

    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: each participant will be requested to draw either number one or two from box. Group number one will receive exer gaming treatment plan Each Patient received twenty four sessions. Each treatment session will of 50 minutes with two minutes rest between each exercise. Group two will receive conventional treatment plan which will include balance training, gait training, stretching and strengthening exercises.Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 14, 2021

Study Start

October 6, 2019

Primary Completion

April 6, 2020

Study Completion

April 21, 2020

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations