- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06231173
Effects of Visual Feedback Therapy on Post Burn Children
June 11, 2024 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 8 to 12 years old children with post burn hand contractures
- Patients with flame burns
- Patients with 2nd degree burns
Exclusion Criteria:
- Patients with hand burns with any post burn complications
- Patients with wound infections
- Patients with 3rd degree burns Patients with hand fractures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Visual feedback therapy and conventional therapy
|
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.
|
|
Active Comparator: Controlled
Conventional therapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 weeks
|
|
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
|
4 weeks
|
|
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
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sana Mushtaq, MS*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Wang 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
February 5, 2024
Study Completion (Actual)
February 5, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Actual)
January 30, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2024
Last Update Submitted That Met QC Criteria
June 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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