Burn HandNCT06231173
Effects of Visual Feedback Therapy on Post Burn Children
A study testing Visual Feedback Therapy and Conventional Therapy and Conventional Therapy in people with Burn Hand, run by Riphah International University at 1 site in Pakistan.
Trial summary
Visual feedback therapy is a cheap, easy, and, most importantly, patient-directed treatment that may improve the recovery of hand motor functional skills. Visual feedback therapy consists of repeated bilateral, symmetrical movements in which the patient moves the affected body part as much as he/she could while… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Burn Hand
- What is being tested?
- Visual Feedback Therapy and Conventional Therapy and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 12 years old children with post burn hand contractures
- Patients with flame burns
- Patients with 2nd degree burns
Who cannot join
- Patients with hand burns with any post burn complications
- Patients with wound infections
- Patients with 3rd degree burns Patients with hand fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Visual Feedback Therapy on Post Burn Hand Contractures in Children
Visual feedback therapy is a cheap, easy, and, most importantly, patient-directed treatment that may improve the recovery of hand motor functional skills. Visual feedback therapy consists of repeated bilateral, symmetrical movements in which the patient moves the affected body part as much as he/she could while observing the reflection.The hands account for less than 5 % of total body surface area. Many burns requiring hospitalization involve the upper extremity considered severe injuries by the American Burn Association and should be referred to specialized care centers to minimize sequella of thermal injury including nail deformities, hypertrophic scars, boutonniere deformity, digit loss, and contractures. Visual feedback therapy is a treatment method based on neuroplasticity of the brain.Although recent studies have demonstrated the benefit of visual feedback therapy for various diseases, research that applies visual feedback therapy to improve the restorative capability of hand function of patients with reduced hand function due to mutilated injury has not been reported yet.
Read the detailed description
This study will be a randomized controlled trial. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. Non probability convenience sampling technique will be used and study will be conducted on 36 patients diagnosed with post burn hand contractures 8-12 years old children. Patient will be randomly categorized into two groups by using flip coin method. Experimental group will receive visual feedback therapy and conventional therapy treatment protocol. Control group will receive only conventional therapy. Pre and Post interventions assessment will be made for both groups. Post burn hand contractures of the patients will be assessed by checking ROMS of hands with goniometer. The ABILHAND questionnaire will also be performed to check the functional movements of hands and visual analogue scale will be used for pain assessment. Data will be analyzed by using SPSS 25.0 statistical tool. Appropriate statistical test will be used after checking normality of data.
- Conditions
- Burn Hand
- Being tested
- Visual Feedback Therapy and Conventional Therapy, Conventional Therapy
- Keywords
- Burns, Goniometer, Hand contractures, Visual feedback therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Feedback Therapy and Conventional TherapyOther
In experimental group individuals will receive visual feedback therapy and Conventional rehabilitation therapy. In visual feedback therapy, bilateral method is used to receive the visual feedback from the mirror. This visual feedback therapy consists of the following parts as the patient is asked to follow the involved hand that did the mimicking while the non-involved side will be performing wrist flexion, wrist extension, ulnar deviation, radial deviation, supination, pronation, and closing hand and opening hand.In conventional therapy, Patients are given a rest time of 20 seconds in each activity and a 1-minute break in each segment in order to reduce fatigue of the noninvolved hand. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied according to subject's tolerance for duration of 15 minutes in each sitting. This treatment protocol will be 5 times/week for 4 weeks in the hospital setting.
Conventional TherapyOther
In control group individuals will receive only conventional therapy. In conventional therapy, Patients are instructed to perform a sandbag and hand grip exercise with a resistive exercise for the non-involved side. At last, patients are instructed to perform a moving small object (ball of wool) and card flip operation to induce wrist and finger movements as functional activities. Patients are given a rest time of 20 seconds in each activity and a 1-minute break in each segment in order to reduce fatigue of the non involved hand. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied according to subject's tolerance for duration of 15 minutes in each sitting. .This treatment protocol will be 5 times/week for 4 weeks in the hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Visual feedback therapy and conventional therapy Receives: Other: Visual Feedback Therapy and Conventional Therapy |
| Controlled | Active comparator | Conventional therapy Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
Goniometer both for upper and lower limb, is the simplest and most extended tool for measuring ROM in the clinical practice It was developed approximately 60 years ago, and its versatility and usability led to this instrument being promptly integrated into the field of physiotherapy and rehabilitation as a helpful evaluation tool. The intra-class correlation coefficients (ICC) ranged from 0.94 to 0.97 from the goniometric measurements
Measured: 4 weeks
THE ABILHAND
The ABILHAND is a Rasch-based assessment that measures patients' perceived difficulty in performing ADLs that require the use of the bilateral upper limbs. It contains 23 items measuring manual ability and is rated on a 3-point response scale. The score, given in logits, is the conversion of the ordinal score into a linear measure of ability located on a unidimensional scale. The ABILHAND is a scale measuring bimanual ability that is often used to determine the level of UE dysfunction. Most of the validity studies on the ABILHAND demonstrated that the ABILHAND measured the concept of motor ability in a "standardized" or natural environment by significant correlations between the ABILHAND and grip strength, motricity, dexterity, or actual UE performance as measured by the accelerometers
Measured: 4 weeks
Visual analogue scale (VAS)
Visual analogue scale (VAS) is a scale used for pain assessment, horizontal line 100mm in length, anchored by word descriptors at each end. The patient was asked to mark on the line the point they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burn HandStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sana Mushtaq, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231173
- Sponsor's protocol ID
- REC/RCR&AHS/23/0732
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tofani M, Santecchia L, Conte A, Berardi A, Galeoto G, Sogos C, Petrarca M, Panuccio F, Castelli E. Effects of Mirror Neurons-Based Rehabilitation Techniques in Hand Injuries: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 May 2;19(9):5526. doi: 10.3390/ijerph19095526.
PubMed 35564920Wang TN, Lin KC, Wu CY, Chung CY, Pei YC, Teng YK. Validity, responsiveness, and clinically important difference of the ABILHAND questionnaire in patients with stroke. Arch Phys Med Rehabil. 2011 Jul;92(7):1086-91. doi: 10.1016/j.apmr.2011.01.020.
PubMed 21704789
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visual Feedback Therapy on Post Burn Hand Contractures in Children
- ClinicalTrials.gov ID
- NCT06231173
- Acronym / sponsor ID
- REC/RCR&AHS/23/0732
- Conditions
- Burn Hand
- Keywords
- Burns, Goniometer, Hand contractures, Visual feedback therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 30 Jan 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.
Visual feedback therapy is a cheap, easy, and, most importantly, patient-directed treatment that may improve the recovery of hand motor functional skills. Visual feedback therapy consists of repeated bilateral, symmetrical movements in which the patient moves the affected body part as much as he/she could while observing the reflection.The hands account for less than 5 % of total body surface area. Many burns requiring hospitalization involve the upper extremity considered severe injuries by the American Burn Association and should be referred to specialized care centers to minimize sequella of thermal injury including nail deformities, hypertrophic scars, boutonniere deformity, digit loss, and contractures. Visual feedback therapy is a treatment method based on neuroplasticity of the brain.Although recent studies have demonstrated the benefit of visual feedback therapy for various diseases, research that applies visual feedback therapy to improve the restorative capability of hand function of patients with reduced hand function due to mutilated injury has not been reported yet.
Detailed description
This study will be a randomized controlled trial. Study will be approved by ethical committee. After that informed consent will be taken and patients will be included in the study based on the inclusion criteria. Non probability convenience sampling technique will be used and study will be conducted on 36 patients diagnosed with post burn hand contractures 8-12 years old children. Patient will be randomly categorized into two groups by using flip coin method. Experimental group will receive visual feedback therapy and conventional therapy treatment protocol. Control group will receive only conventional therapy. Pre and Post interventions assessment will be made for both groups. Post burn hand contractures of the patients will be assessed by checking ROMS of hands with goniometer. The ABILHAND questionnaire will also be performed to check the functional movements of hands and visual analogue scale will be used for pain assessment. Data will be analyzed by using SPSS 25.0 statistical tool. Appropriate statistical test will be used after checking normality of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Visual Feedback Therapy and Conventional TherapyVisual feedback therapy and conventional therapy |
| Controlled | Active comparator | Other: Conventional TherapyConventional therapy |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8 to 12 years old children with post burn hand contractures
- Patients with flame burns
- Patients with 2nd degree burns
Key exclusion criteria (3 listed)
- Patients with hand burns with any post burn complications
- Patients with wound infections
- Patients with 3rd degree burns Patients with hand fractures
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 |
|---|---|---|
| Visual Feedback Therapy and Conventional TherapyIn experimental group individuals will receive visual feedback therapy and Conventional rehabilitation therapy. In visual feedback therapy, bilateral method is used to receive the visual feedback from the mirror. This visual feedback therapy consists of the following parts as the patient is asked to follow the involved hand that did the mimicking while the non-involved side will be performing wrist flexion, wrist extension, ulnar deviation, radial deviation, supination, pronation, and closing hand and opening hand.In conventional therapy, Patients are given a rest time of 20 seconds in each activity and a 1-minute break in each segment in order to reduce fatigue of the noninvolved hand. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied according to subject's tolerance for duration of 15 minutes in each sitting. This treatment protocol will be 5 times/week for 4 weeks in the hospital setting. | Other | Experimental |
| Conventional TherapyIn control group individuals will receive only conventional therapy. In conventional therapy, Patients are instructed to perform a sandbag and hand grip exercise with a resistive exercise for the non-involved side. At last, patients are instructed to perform a moving small object (ball of wool) and card flip operation to induce wrist and finger movements as functional activities. Patients are given a rest time of 20 seconds in each activity and a 1-minute break in each segment in order to reduce fatigue of the non involved hand. The treatment will be applied by the therapist standing at the side of the patient. Then technique will be applied according to subject's tolerance for duration of 15 minutes in each sitting. .This treatment protocol will be 5 times/week for 4 weeks in the hospital setting. | Other | Controlled |
Primary outcome
Goniometer
Time frame: 4 weeks
Goniometer both for upper and lower limb, is the simplest and most extended tool for measuring ROM in the clinical practice It was developed approximately 60 years ago, and its versatility and usability led to this instrument being promptly integrated into the field of physiotherapy and rehabilitation as a helpful evaluation tool. The intra-class correlation coefficients (ICC) ranged from 0.94 to 0.97 from the goniometric measurements
THE ABILHAND
Time frame: 4 weeks
The ABILHAND is a Rasch-based assessment that measures patients' perceived difficulty in performing ADLs that require the use of the bilateral upper limbs. It contains 23 items measuring manual ability and is rated on a 3-point response scale. The score, given in logits, is the conversion of the ordinal score into a linear measure of ability located on a unidimensional scale. The ABILHAND is a scale measuring bimanual ability that is often used to determine the level of UE dysfunction. Most of the validity studies on the ABILHAND demonstrated that the ABILHAND measured the concept of motor ability in a "standardized" or natural environment by significant correlations between the ABILHAND and grip strength, motricity, dexterity, or actual UE performance as measured by the accelerometers
Visual analogue scale (VAS)
Time frame: 4 weeks
Visual analogue scale (VAS) is a scale used for pain assessment, horizontal line 100mm in length, anchored by word descriptors at each end. The patient was asked to mark on the line the point they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks
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 13 Jun 2024.
- Background: PubMed 35564920Tofani M, Santecchia L, Conte A, Berardi A, Galeoto G, Sogos C, Petrarca M, Panuccio F, Castelli E. Effects of Mirror Neurons-Based Rehabilitation Techniques in Hand Injuries: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 May 2;19(9):5526. doi: 10.3390/ijerph19095526.
- Background: PubMed 21704789Wang TN, Lin KC, Wu CY, Chung CY, Pei YC, Teng YK. Validity, responsiveness, and clinically important difference of the ABILHAND questionnaire in patients with stroke. Arch Phys Med Rehabil. 2011 Jul;92(7):1086-91. doi: 10.1016/j.apmr.2011.01.020.
- 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.
Sana Mushtaq, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Feedback Therapy and Conventional Therapy and Conventional Therapy in people with Burn Hand, run by Riphah International 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 3 inclusion and 3 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 13 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?
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?
Goniometer (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT06231173, which also lists 2 linked publications.
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 13 Jun 2024.