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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spasm
• Intervention / Treatment: Diagnostic test: Deep Friction massage; Combination product: Therapeutic exercises

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Deep Friction massage	Diagnostic test: Deep Friction massage; The calf muscles received a firm, deep-circulation massage with fingertip pressure
Experimental: Therapeutic exercises	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): October 29, 2024

Study Registration Dates

• First Submitted: May 25, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Spasm
• Other Study ID Numbers: MSRSW/Batch-Fall22/718

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