Effect of Constraint Induced Movement Therapy on Burned Dominant Hand FunctionCIMTNCT06708273
Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function
A study testing Constraint induced movement therapy and Positioning - stretching in people with Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function and Hand Burn, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of constraint induced movement therapy on burned dominant hand function Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function, Hand Burn
- What is being tested?
- Constraint induced movement therapy and Positioning - stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2024to 26 Aug 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of patient 20 to 35
- both male and female
- suffer from dorsal hand dominant burn healed spontaneously or by graft
- TBSA less than 20%
- All patient active before injury.
Who cannot join
- patient with fracture
- patient with crush injuries
- patient with contralateral hand burn
- Patient with cardiovascular injury
Trial locations and contacts
1 site in 1 country.
About this study
Effect of constraint induced movement therapy on burned dominant hand function
Read the detailed description
Effect of constraint induced movement therapy on burned dominant hand function
We investigate the Effect of constraint induced movement therapy on burned dominant hand function by using various measurement tools :
- Hand grip strength by Hand held dynamometer
- Metacarpophalangeal joint flexion (MCP) by goniometer
- Function by michgan hand questionnaire A randomised controlled trial (2 groups) First group will receive constraint induced movement therapy (glove mitt) on sound hand .
Second group will receive the traditional treatment ( stretching - positioning ) We do the assessment before treatment and (4-8) after the start of treatment process.
- Being tested
- Constraint induced movement therapy, Positioning - stretching
- Keywords
- Hand function - CIMT - Constraint - Dominant, hand, function, constraint induced movement therapy, burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint induced movement therapyOther
Also called CIMT
Constraint the sound side and encourage movement of the burned side
Positioning - stretchingOther
Position hand in functional hand position - stretching against deformity position
constraint induced movement therapyOther
constraining sound hand to enforce patient to use affected burned dominant hand
| Study group | Role | What they receive |
|---|---|---|
| group 1 received constraint induced movement therapy + traditional treatment | Experimental | group 1 received constraint induced movement therapy + traditional treatment we will constraint affected hand and enforce patient to use affected side Receives: Other: Constraint induced movement therapy; Other: Positioning - stretching |
| traditional treatment for hand burn positioning - RANGE OF MOTION | Active comparator | traditional treatment for hand burn positioning - RANGE OF MOTION Receives: Other: Positioning - stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Strength measured by hand held dynamometer
Measured: 8 weeks for each case
Metacarpophalangeal joint flexion
Range of motion by goinometer
Measured: 8 weeks for each case
Hand function
By arabic version of michgan hand qurstionaire
Measured: 8 weeks for each case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start22 May 2024
- Primary completion1 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Constraint Induced Movement Therapy on Burned Dominant Hand FunctionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elbadri Farouk Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708273
- Sponsor's protocol ID
- P.T.REC/012/005218
- Acronym
- CIMT
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function
- ClinicalTrials.gov ID
- NCT06708273
- Acronym / sponsor ID
- CIMT / P.T.REC/012/005218
- Keywords
- Hand function - CIMT - Constraint - Dominant, hand, function, constraint induced movement therapy, burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 27 Nov 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.
Effect of constraint induced movement therapy on burned dominant hand function
Detailed description
Effect of constraint induced movement therapy on burned dominant hand function
We investigate the Effect of constraint induced movement therapy on burned dominant hand function by using various measurement tools :
- Hand grip strength by Hand held dynamometer
- Metacarpophalangeal joint flexion (MCP) by goniometer
- Function by michgan hand questionnaire A randomised controlled trial (2 groups) First group will receive constraint induced movement therapy (glove mitt) on sound hand .
Second group will receive the traditional treatment ( stretching - positioning ) We do the assessment before treatment and (4-8) after the start of treatment process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 received constraint induced movement therapy + traditional treatment | Experimental | Other: Constraint induced movement therapy, Other: Positioning - stretchinggroup 1 received constraint induced movement therapy + traditional treatment we will constraint affected hand and enforce patient to use affected side |
| traditional treatment for hand burn positioning - RANGE OF MOTION | Active comparator | Other: Positioning - stretchingtraditional treatment for hand burn positioning - RANGE OF MOTION |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age of patient 20 to 35
- both male and female
- suffer from dorsal hand dominant burn healed spontaneously or by graft
- TBSA less than 20%
- All patient active before injury.
Key exclusion criteria (4 listed)
- patient with fracture
- patient with crush injuries
- patient with contralateral hand burn
- Patient with cardiovascular injury
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 |
|---|---|---|
| Constraint induced movement therapyAlso: CIMTConstraint the sound side and encourage movement of the burned side | Other | group 1 received constraint induced movement therapy + traditional treatment |
| Positioning - stretchingPosition hand in functional hand position - stretching against deformity position | Other | group 1 received constraint induced movement therapy + traditional treatment, traditional treatment for hand burn positioning - RANGE OF MOTION |
| constraint induced movement therapyconstraining sound hand to enforce patient to use affected burned dominant hand | Other | group 1 received constraint induced movement therapy + traditional treatment |
Primary outcome
Hand grip strength
Time frame: 8 weeks for each case
Strength measured by hand held dynamometer
Metacarpophalangeal joint flexion
Time frame: 8 weeks for each case
Range of motion by goinometer
Hand function
Time frame: 8 weeks for each case
By arabic version of michgan hand qurstionaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided
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 Constraint induced movement therapy and Positioning - stretching in people with Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function and Hand Burn, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 27 Nov 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hand grip strength (time frame: 8 weeks for each case). 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 27 Nov 2024.