Comparison of Ergon Instruments-Assisted Soft Tissue Mobilization With Compressive Myofascial Release

Not Applicable

Completed

• Conditions: Plantar Fasciitis
• Interventions: Other: Instrument-assisted Soft Tissue Mobilization; Other: Compressive Myofascial Release Technique

• Registration Number: NCT05258188
• Lead Sponsor: Riphah International University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-20
• Study First Posted: 2022-02-28
• Primary Completion: 2022-03-25
• Study Completion: 2022-03-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instrument-assisted Soft Tissue Mobilization	Instrument-assisted Soft Tissue Mobilization	1. Warm-up will be performed for 10 to 15 minutes by light jogging, elliptical machine, stationary cycle or an upper body ergometer 2. Instrument-assisted Soft Tissue Mobilization , will be applied at 30 to 60 degrees angle for 40 to 120 seconds 3. Stretching, for 30 seconds (3 rep) 4. Strengthening exercises, high repetitions with low intensity exercise 5. Cryotherapy for 10 to 20 min
Compressive Myofascial Release Technique	Compressive Myofascial Release Technique	Compressive myofascial release technique will be applied 5 minutes, after a warmup of 10 to 15 minutes.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	12th Week	The Visual Analog Scale is a 10 cm line with anchor statements on the left, no pain and on the right, extreme pain.
Range of Motion	12th Week	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.
Foot and Ankle Disability Index	12th Week	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.
Foot and Ankle Ability Measure	12th Week	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.

Trial Locations

Locations (1)

Ripah International University; 🇵🇰 Faisalabad, Punjab, Pakistan