SpasmNCT06441253
Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms
A study testing Deep Friction massage and Therapeutic exercises in people with Spasm, run by Superior University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasm
- What is being tested?
- Deep Friction massage and Therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 29 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Ramay Clinic (Physiotherapy and Orthopedic Department)
Lahore, Punjab Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Spasm
- Being tested
- Deep Friction massage, Therapeutic exercises
- Medical subject headings
- Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Friction massageDiagnostic test
The calf muscles received a firm, deep-circulation massage with fingertip pressure
Therapeutic exercisesCombination product
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)
| Study group | Role | What they receive |
|---|---|---|
| Deep Friction massage | Other | Not described Receives: Diagnostic Test: Deep Friction massage |
| Therapeutic exercises | Experimental | Not described Receives: Combination Product: Therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion29 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasmStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441253
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/718
- Status last verified
- Jun 2024
- First submitted
- 25 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Portable Wedge Device for Calf Stretching to Alleviate Strain and Spasms: A RCT Study
- ClinicalTrials.gov ID
- NCT06441253
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/718
- Conditions
- Spasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Friction massage | Other | Diagnostic Test: Deep Friction massage |
| Therapeutic exercises | Experimental | Combination Product: Therapeutic exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Friction massageThe calf muscles received a firm, deep-circulation massage with fingertip pressure | Diagnostic test | Deep Friction massage |
| Therapeutic exercisesFour 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) | Combination product | Therapeutic exercises |
Primary outcome
Visual Analog Scale
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Friction massage and Therapeutic exercises in people with Spasm, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.