Plantar FasciitisNCT05258188
Comparison of Ergon Instruments-Assisted Soft Tissue Mobilization With Compressive Myofascial Release
A study testing Instrument-assisted Soft Tissue Mobilization and Compressive Myofascial Release Technique in people with Plantar Fasciitis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Instrument-assisted Soft Tissue Mobilization and Compressive Myofascial Release Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recent foot injury,
- Fracture,
- Infections,
- Surgical procedures,
- Tendon injury,
- Hypermobility,
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- Neuromuscular disorders,
- Impaired sensation,
- Open sores,
- Skin disease,
- Active deep vein thrombosis or thrombophlebitis,
- Bruises,
- Varicose veins,
- Burn scars
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
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
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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Instrument-assisted Soft Tissue Mobilization, Compressive Myofascial Release Technique
- Keywords
- Plantar Fascitis, Randomized Control Trial, Myofascial Release, Soft Tissue Mobilization, Ergon Instruments, Comparison
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-assisted Soft Tissue MobilizationOther
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 TechniqueOther
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
| Study group | Role | What they receive |
|---|---|---|
| Instrument-assisted Soft Tissue Mobilization | Experimental | 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 Receives: Other: Instrument-assisted Soft Tissue Mobilization |
| Compressive Myofascial Release Technique | Experimental | Compressive myofascial release technique will be applied 5 minutes, after a warmup of 10 to 15 minutes. Receives: Other: Compressive Myofascial Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Mar 2021
- Primary completion25 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258188
- Sponsor's protocol ID
- REC-FSD-00266
- Status last verified
- May 2022
- First submitted
- 20 Feb 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05258188
- Acronym / sponsor ID
- REC-FSD-00266
- Conditions
- Plantar Fasciitis
- Keywords
- Plantar Fascitis, Randomized Control Trial, Myofascial Release, Soft Tissue Mobilization, Ergon Instruments, Comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrument-assisted Soft Tissue Mobilization | Experimental | Other: Instrument-assisted Soft Tissue Mobilization1. 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 | Experimental | Other: Compressive Myofascial Release TechniqueCompressive myofascial release technique will be applied 5 minutes, after a warmup of 10 to 15 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Inability to achieve 20 degrees of active dorsiflexion,
- Heel pain,
- Mid foot pain,
- Heal swelling,
- Mid foot swelling,
Key exclusion criteria (14 listed)
- Recent foot injury,
- Fracture,
- Infections,
- Surgical procedures,
- Tendon injury,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrument-assisted Soft Tissue MobilizationInstrument-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. | Other | Instrument-assisted Soft Tissue Mobilization |
| Compressive Myofascial Release TechniqueCompressive 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 | Other | Compressive Myofascial Release Technique |
Primary outcome
Range of Motion
Time frame: 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.
Visual Analogue Scale
Time frame: 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.
Foot and Ankle Disability Index
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Kashif study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-assisted Soft Tissue Mobilization and Compressive Myofascial Release Technique in people with Plantar Fasciitis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 12th Week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.