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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258188
Other study ID # REC-FSD-00266
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 31, 2022

Study information

Verified date May 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to investigate the effects of Virtual Reality and Motor Imagery along with Routine Physical Therapy in motor function and balance in patients with Parkinson disease.


Description:

This randomized control trial is the single blinded, single centered study. Standard Protocol Items: Recommendations for Interventional Trials guidelines are used as study protocol. Sixty three patients of Parkinson Disease (Modified Hoehn and Yahr stages I-III) will randomly allocate into three groups. Group A will be given a 60 min session of Virtual Reality along with Routine Physical Therapy. Group B will be given a 60 min session of Motor Imagery along with Routine Physical Therapy. Group C will be given a 40 min session of Routine Physical Therapy and after a short period of rest,20 min for walking and cycling. These treatment sessions will be given to each group at every alternative day (3 days per week) for 12 weeks. Outcome measures are 1. Berg Balance Scale 2. Activities Specific Balance Confidence Scale 3. The Unified Parkinson Disease Rating Scale (part III) The Assessments will be recorded at baseline, at 6th and 12th weeks of therapy, and after one month of discontinuation of therapy.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 31, 2022
Est. primary completion date March 25, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Inability to achieve 20 degrees of active dorsiflexion, - Heel pain, - Mid foot pain, - Heal swelling, - Mid foot swelling, - Achilles' tendon tightness diagnosed on the base of Windlass test Exclusion Criteria: - Recent foot injury, - Fracture, - Infections, - Surgical procedures, - Tendon injury, - Hypermobility, - Neuromuscular disorders, - Impaired sensation, - Open sores, - Skin disease, - Active deep vein thrombosis or thrombophlebitis, - Bruises, - Varicose veins, - Burn scars

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Instrument-assisted Soft Tissue Mobilization
Instrument-assisted soft tissue mobilization is used for a mechanical benefit for the therapist providing deeper approach and braces remodeling of connective tissues through dissolution of extravagant fibrosis, while provoking repair and reconstructing forwarded by the recruitment of fibroblast.
Compressive Myofascial Release Technique
Compressive Myofascial Release Technique is a technique of soft tissue stretching that uses compression and sustained myofascial stretches to create a releasing force in the targeted area

Locations

Country Name City State
Pakistan Ripah International University Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion Goniometer has been the most widely used tool for measuring joint range of motion. To ensure reliable measurement, standardized, specific positions and landmarks are used to measure each joint movement. 12th Week
Primary Visual Analogue Scale The Visual Analog Scale is a 10 cm line with anchor statements on the left, no pain and on the right, extreme pain. 12th Week
Primary Foot and Ankle Disability Index The Foot and Ankle Disability Index has 26 items. Each item is scored from 0; unable to do, to 4; no difficulty at all. The Foot and Ankle Disability Index has a total point value of 104 points. 12th Week
Primary Foot and Ankle Ability Measure The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument/questionaire developed to assess physical function for individuals with foot and ankle related impairments. 8-item Sports Subscale.
Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
12th Week
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