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

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Instrument-assisted Soft Tissue Mobilization
Compressive Myofascial Release Technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Plantar Fascitis, Randomized Control Trial, Myofascial Release, Soft Tissue Mobilization, Ergon Instruments, Comparison

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ripah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Instrument-assisted Soft Tissue Mobilization

Compressive Myofascial Release Technique

Arm Description

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

Compressive myofascial release technique will be applied 5 minutes, after a warmup of 10 to 15 minutes.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05258188
Brief Title
Comparison of Ergon Instruments-Assisted Soft Tissue Mobilization With Compressive Myofascial Release
Official Title
Study Comparing the Effectiveness of Ergon Instruments-Assisted Soft Tissue Mobilization Techniques With Compressive Myofascial Release for Plantar Fasciitis: A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Berg Balance Scale Activities Specific Balance Confidence Scale 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Plantar Fascitis, Randomized Control Trial, Myofascial Release, Soft Tissue Mobilization, Ergon Instruments, Comparison

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Our study will be single-blinded, outcome assessor-blinded. The assessor will be blinded to avoid being biased during the outcome assessment.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instrument-assisted Soft Tissue Mobilization
Arm Type
Experimental
Arm Description
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
Arm Title
Compressive Myofascial Release Technique
Arm Type
Experimental
Arm Description
Compressive myofascial release technique will be applied 5 minutes, after a warmup of 10 to 15 minutes.
Intervention Type
Other
Intervention Name(s)
Instrument-assisted Soft Tissue Mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Compressive Myofascial Release Technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Range of Motion
Description
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.
Time Frame
12th Week
Title
Visual Analogue Scale
Description
The Visual Analog Scale is a 10 cm line with anchor statements on the left, no pain and on the right, extreme pain.
Time Frame
12th Week
Title
Foot and Ankle Disability Index
Description
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.
Time Frame
12th Week
Title
Foot and Ankle Ability Measure
Description
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.
Time Frame
12th Week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Ripah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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