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

NCT06441253 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/718
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spasm

Outcome Measures

Primary Outcomes (3)

• 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".

  12 Months

• 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.

  12 months

• 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.

  12 months

Study Arms (2)

Deep Friction massage

OTHER

Diagnostic Test: Deep Friction massage

Therapeutic exercises

EXPERIMENTAL

Combination Product: Therapeutic exercises

Interventions

Deep Friction massage DIAGNOSTIC_TEST

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

Deep Friction massage

Therapeutic exercises COMBINATION_PRODUCT

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)

Therapeutic exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department)

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Spasm

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: June 4, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: October 29, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)