Wrist-DropNCT05875844
Wrist Splint and Occupational Therapy to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop
A study testing Wrist Splint and Occupational Therapy in people with Wrist-Drop, run by Superior University at 1 site in Pakistan.
Trial summary
To determine effectiveness of wrist splint and occupational therapy to improve pain, mobility and functional status in patients with wrist drop. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Wrist-Drop
- What is being tested?
- Wrist Splint and Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 Aug 2023
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • People with wrist drop
- People between 20 to 40 years will be included (male and female)
- Post-operative patients (nerve grafting and plastic surgery)
- Patients with findings of nerve compression will be included
Who cannot join
- • People with nerve injuries other than radial nerve such as ulnar or median nerve
- People suffering with other neurological disorders.
- People who are not able to follow instructions
- Any traumatic history
- Diabetic patients, thyroid issues, pregnant females
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Chaudary Muhammad Akram Teaching Hospital
Lahore, Punjab Province
About this study
Official title: Effectiveness of Wrist Splint and Occupational Therapy to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop
To determine effectiveness of wrist splint and occupational therapy to improve pain, mobility and functional status in patients with wrist drop.
- Conditions
- Wrist-Drop
- Being tested
- Wrist Splint, Occupational Therapy
- Medical subject headings
- Radial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist SplintDiagnostic test
Wrist Splint to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop
Occupational TherapyDiagnostic test
Occupational Therapy to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop
| Study group | Role | What they receive |
|---|---|---|
| Wrist Splint | Other | Not described Receives: Diagnostic Test: Wrist Splint |
| Occupational Therapy | Experimental | Not described Receives: Diagnostic Test: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH scale (0-100)
DASH questionnaire for function on the scale of (0-100) worst zero- hundred normal
Measured: 6 Months
VAS on the scale (1-10)
VAS for pain for pain (0-10) 0 for normal, 10 for worst pain
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist-DropStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- NCT05875844
- Sponsor's protocol ID
- DPT/Batch-Fall18/545
- Status last verified
- May 2023
- First submitted
- 18 Mar 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Wrist Splint and Occupational Therapy to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop
- ClinicalTrials.gov ID
- NCT05875844
- Acronym / sponsor ID
- DPT/Batch-Fall18/545
- Conditions
- Wrist-Drop
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 25 May 2023 (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.
To determine effectiveness of wrist splint and occupational therapy to improve pain, mobility and functional status in patients with wrist drop.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wrist Splint | Other | Diagnostic Test: Wrist Splint |
| Occupational Therapy | Experimental | Diagnostic Test: Occupational Therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • People with wrist drop
Key exclusion criteria (5 listed)
- • People with nerve injuries other than radial nerve such as ulnar or median nerve
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 |
|---|---|---|
| Wrist SplintWrist Splint to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop | Diagnostic test | Wrist Splint |
| Occupational TherapyOccupational Therapy to Improve Pain, Mobility and Functional Status in Patients With Wrist Drop | Diagnostic test | Occupational Therapy |
Primary outcome
DASH scale (0-100)
Time frame: 6 Months
DASH questionnaire for function on the scale of (0-100) worst zero- hundred normal
VAS on the scale (1-10)
Time frame: 6 Months
VAS for pain for pain (0-10) 0 for normal, 10 for worst pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Splint and Occupational Therapy in people with Wrist-Drop, 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 5 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 25 May 2023. 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?
Contact Mubeen Nasir, DPT (+923144248042, mubeennasir95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH scale (0-100) (time frame: 6 Months). The study lists 2 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 25 May 2023.