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

Spasm Clinical Trial

Official title:

Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms: A RCT Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06441253
• Other study ID #: MSRSW/Batch-Fall22/718
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: October 29, 2024

Study information

• Verified date: June 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: October 29, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spasm

Intervention

Diagnostic Test:
• Deep Friction massage
The calf muscles received a firm, deep-circulation massage with fingertip pressure

Combination Product:
• Therapeutic 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)

Locations

Country	Name	City	State
Pakistan	Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department)	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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