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

Not Applicable

Active, not recruiting

• Conditions: Spasm
• Interventions: Diagnostic Test: Deep Friction massage; Combination Product: Therapeutic exercises

• Registration Number: NCT06441253
• Lead Sponsor: Superior University

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.

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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-05-01
• Study First Submitted: 2024-05-25
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Study Completion: 2024-10-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

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

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Friction massage	Deep Friction massage	-
Therapeutic exercises	Therapeutic exercises	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	12 Months	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".
Functional Disability Scale for Ankle (FADI)	12 months	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.
Range of motion (ROM)	12 months	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.

Trial Locations

Locations (1)

Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department); 🇵🇰 Lahore, Punjab, Pakistan