ClinicalTrials.gg
Status unknownNCT06441253Updated Jun 4, 2024

Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms

An interventional study of Deep Friction massage and Therapeutic exercises in Spasm, sponsored by Superior University. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Superior University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This research aimed to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues.

Read the detailed description

By combining economical, ergonomic principles and user-friendly features, the proposed device offered individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms. Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.

02

Conditions studied

  • Spasm

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03

In context

Spasm

147 studies on the registry are indexed under Spasm; 15 are open to participants now.

This study's enrollment of 26 is below the median of 52 across 119 interventional studies indexed under Spasm.

Browse Spasm studies →

Lead sponsor

Superior University is the lead sponsor of 253 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female patients diagnosed with Calf Strain and Spasm
  • Age above 18
  • Participants who are volunteer for the study
  • Patients who suffer from leg pain or functional disability

Exclusion criteria

Exclusion Criteria:

  • Unconscious patients
  • Patients with difficulty in seeing and hearing
  • Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
  • Patient history of severe mobility disorder
  • Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
  • Decline to participate in this study
  • Active fracture and dislocations
  • Arthritic disorders (such as osteoarthritis, Rheumatoid Arthritis, Psoriatic Arthritis, and Fibromyalgia)
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    Deep Friction massage

    Diagnostic Test: Deep Friction massage

  • Experimental
    Therapeutic exercises

    Combination Product: Therapeutic exercises

Interventions

  • Diagnostic testDeep Friction massage

    The calf muscles received a firm, deep-circulation massage with fingertip pressure

  • Combination productTherapeutic exercises

    Four stretching exercises were performed for twenty minutes, five minutes for each technique, and eight to ten repetitions of each exercise (calf wall stretch, back knee straight, bilateral calf stretches, knees straight, ankle plantarflexion/dorsiflexion)

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 for "no pain" and 10 for "worst pain".

    Time frame: 12 Months

  2. Functional Disability Scale for Ankle (FADI)

    The FADI has 26 items. Each item is scored from 0 (unable to do) to 4 (no difficulty at all). The 4 pain items of the FADI are scored 0 (unbearable) to 4 (none). The FADI has a total point value of 104 points, whereas the FADI Sport has a total point value of 32 points.

    Time frame: 12 months

  3. Range of motion (ROM)

    This tool measures the angle of dorsiflexion before and after the intervention, offering insights into the functional improvements resulting from the use of the portable wedge device. Additionally, participant satisfaction and compliance will be assessed through a structured questionnaire.

    Time frame: 12 months

07

Study locations

1 site
  • Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department)
    Lahore, Punjab Province, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06441253
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Jun 4, 2024
Start date
Nov 1, 2023
Primary completion
May 1, 2024
Completion
Oct 29, 2024 (estimated)
Last update
Jun 4, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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