NCT04884646

Brief Summary

The aim of this study is to investigate the effects of VR and MI techniques in addition to routine physical therapy on motor skills, balance and ADL in patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started May 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

May 7, 2021

Last Update Submit

June 14, 2021

Conditions

Keywords

ParkinsonVirtual RealityMotor ImageryRoutine Physical Therapy

Outcome Measures

Primary Outcomes (3)

  • Unified Parkinson's disease Rating Scale Part II

    This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales: Sub-scale II comprises the evaluation of activities in daily living. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability .

    3 months

  • Unified Parkinson's disease Rating Scale Part III

    This is a subjective instrument that is widely used in clinical settings for patients with Parkinson's disease. This scale comprises 31 elements, which are divided into three sub-scales and sub-scale III evaluates the motor system. A possible maximum of 199 points can be scored on this scale. A score of 199 refers to complete disability and 0 refers to the absence of disability

    3 months

  • Berg Balance Scale (BBS)

    The scale has been established as the most widely used assessment tool in clinical settings to identify changes in balance performance. A score of less than 45 is considered a limit for the risk of falling, while a score of 56 relates to functional balance

    3 months

Secondary Outcomes (1)

  • Activities-specific Balance Confidence Scale (ABC):

    3 months

Study Arms (3)

Virtual Reality with Routine Physical Therapy

EXPERIMENTAL

The duration of the VR will be from 10 to 15 minutes during each session and Routine Physical Therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training)

Other: VR with Routine physical therapy and Virtual reality

Motor imagery technique with Routine Physical Therapy

EXPERIMENTAL

Motor Imagery techniques will be given for 5 to 10 minutes along with routine physical therapy for 40 minutes which consists of warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training)

Other: Motor Imagery with Routine physical therapy

Routine Physical Therapy

EXPERIMENTAL

Only routine physical therapy will be given (including warming-up, stretching, strengthening and active exercises for relaxation, coordination exercises for limbs, trunk, neck, and gait training)

Other: Routine physical therapy

Interventions

VR group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks

Also known as: Rehabilitation following VR with Routine physical therapy treatment
Virtual Reality with Routine Physical Therapy

MI group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks

Also known as: Rehabilitation following MI with Routine physical therapy treatment
Motor imagery technique with Routine Physical Therapy

Group A will be given routine physical therapy in 40-min sessions and 20 min of walking and cycling with a short period of rest, every alternate day (3 days per week) for 12 weeks

Also known as: Rehabilitation following Routine physical therapy treatment
Routine Physical Therapy

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's disease
  • Modified Hoehn and Yahr Scale(H\&Y stages I to III)
  • Between the ages of 50 and 80 years of both genders
  • Independent in transfers
  • A score equal to or greater than 24 on the Mini-Mental State Examination (MMSE), and
  • Previous lack of participation in balance or motor training.

You may not qualify if:

  • History of any neurological conditions such as stroke, multiple sclerosis, epilepsy other than Parkinson's disease,
  • History of orthopedic issues such as pain, fracture, or lower limb pathology,
  • History of visual abnormalities,
  • History of any chronic or cardiovascular pathology that can interfere with the transfer procedure or can affect the training sessions,
  • The participants having severe dyskinesia or "on-off" phases,
  • Previous history of surgery for PD,
  • History of virtual games used for treatment in the past three months, and
  • Virtual game phobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Muhammad Kashif

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as accessor of the study would be kept blind of the treatment group to which patient would be allocated.After the complete initial screening process, every recruited patient will be accessed by an independent assessor, expert will use outcome measuring tools. his will be recorded as baseline measurement assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 13, 2021

Study Start

May 1, 2020

Primary Completion

June 12, 2021

Study Completion

June 12, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations