Effects of Active and PRT on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fascitis

December 26, 2023 updated by: Riphah International University

Comparative Effects of Active and Positional Release Technique on Pain, Function and Temporospatial Gait Parameters in Runners With Plantar Fasciitis

The study is randomized and single -blinded. Ethical approval is taken from ethical committee of Riphah International university Lahore.Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A single blinded randomized clinical trial will be conducted on 26 subjects diagnosed for planter fasciitis from Jawad Club Faisalabad and Alfatah Sports Club, Faisalabad by looking for symptoms and tenderness at heel as mentioned in inclusion criteria and will confirmed by windlass test. Participants who will meet criteria will be requested to give verbal consent and to sign written consent form. After signing consent form participants will be allocated to the group A and Group B by using computerized generated randomization. Group A will receive ultrasound then Active release technique while group B will receive ultrasound and Positional release technique for 4 weeks. Treatment sessions will be 12 sessions, 3 sessions per week on alternative days for 4 weeks. Pain will be measured by Numerical Pain Rating Scale (NPRS), Foot and ankle disability will be assessed by Foot Function Index (FFI), while gait parameters i.e. walking speed will be measured by 4-meter walking test, and step and stride length will be evaluated by measuring tape by taking foot prints before and after the 4 weeks of treatment period. Data will be analyzed through statistical package for the social sciences (SPSS) version 22.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan, 38000
        • Recruiting
        • Jawad club, Alfatah sports complex
        • Contact:
        • Contact:
        • Principal Investigator:
          • Athar Azeem, dpt
        • Sub-Investigator:
          • Malia younas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male runners age between 18-30 years
  • Duration of running at least 6 months
  • Positive windlass test
  • Patients with unilateral or bilateral plantar fasciitis

Exclusion Criteria:

  • Recent accidental foot or ankle injury
  • Previous lower-body surgical intervention within 6 months
  • Recent fractures in the lower limb (femur, tibia, fibula or foot bones) within 6 months
  • Diagnosed musculoskeletal disorders (rheumatoid arthritis, calcaneal spurs)
  • Diagnosed neuropathy, local and systemic neurologic disorders (including sciatica, tarsal tunnel syndrome, nerve entrapment of abductor digiti minimi and posterior tibial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active release technique
ART performed from long sitting position, the therapist started by shortening the muscle or fascia of affected limb then apply very specific pressure with hand as we stretch tissue is lengthened. Active movement is done whenever possible according to the instructions given by therapist. ART for 8-10 minutes will be given.
Other: Active release technique
This include active release technique for 4 weeks
Experimental: Positional release technique
Positional release technique where participant lie supine with the affected limb out of the plinth and then by application of brief mechanical pressure on tender point with one fingertip in order to determine tenderness. The foot should then be positioned, most probably into pure plantarflexion and gentle fine-tuned by rotation, until the score in the tender point has reduce by at least 70%. This position is held for 90 seconds with 3 repetitions i.e. total of 270 seconds was given.
Other: Positional release technique
This include positional release technique for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait parameters
Time Frame: pre and 4 weeks post intervention
gait parameters will be measured by 4-meter walking test
pre and 4 weeks post intervention
Foot Function
Time Frame: pre and 4 weeks post intervention
Foot function will be assessed by Foot Function Index (FFI),
pre and 4 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Athar Azeem, Dpt, Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/23/0432

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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