Spasm Clinical Trial
Official title:
Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms: A RCT Study
Verified date | June 2024 |
Source | Superior University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Pakistan | Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department) | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Superior University |
Pakistan,
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 |
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