Skip to content

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06441253
Enrollment
26
Registered
2024-06-04
Start date
2023-11-01
Completion date
2024-10-29
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasm

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.

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)

Sponsors

Superior University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale12 Monthssubjective 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 monthsThe 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 monthsThis 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026