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

Study Comparing the Effectiveness of Ergon Instruments-Assisted Soft Tissue Mobilization Techniques With Compressive Myofascial Release for Plantar Fasciitis: A Randomised Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Instrument-assisted Soft Tissue Mobilization; Other: Compressive Myofascial Release Technique

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 38000
      • Ripah International university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Randomized Control Trial; Myofascial Release; Comparison; Plantar Fascitis; Soft Tissue Mobilization; Ergon Instruments
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: REC-FSD-00266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No