Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06237361
Other study ID # RHPT/023/014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2022
Est. completion date December 15, 2023

Study information

Verified date January 2024
Source Qassim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated the effects of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children with burn injuries. In a twelve-week randomized clinical trial involving 60 children, those who received Pilates exercises in addition to traditional physical therapy showed significant improvements in muscle strength, functional capacity, and overall quality of life compared to those who received traditional therapy alone. The findings suggest that incorporating Pilates exercises into rehabilitation programs may enhance outcomes for children recovering from burn injuries.


Description:

This research focused on examining the impact of Pilates exercises on lower limb muscle strength, functional capacity, and quality of life in children recuperating from burn injuries. The study, conducted as a twelve-week randomized clinical trial with 60 participants, found notable improvements in various aspects for the group receiving Pilates exercises alongside traditional physical therapy. Specifically, enhancements in muscle strength (including hip flexors, extensors, abductors, and more), functional capacity, and overall quality of life scores were statistically significant in the Pilates group compared to those undergoing traditional therapy alone. This suggests a positive influence of Pilates exercises on the rehabilitation of children with lower limb burns. The investigation delved into the potential benefits of Pilates exercises, emphasizing their role in augmenting muscle strength, functional capacity, and overall well-being. The study participants, aged 10 to 15 years and recovering from lower limb burns, were randomly assigned to either a control group receiving only traditional physical therapy or a Pilates group combining Pilates exercises with traditional therapy. The outcomes demonstrated significant differences favoring the Pilates group, not only in terms of lower limb muscle strength but also functional capacity, as assessed by the 6-minute walk test, and overall quality of life scores measured through the Pediatric Quality of Life Inventory. The findings suggest that incorporating Pilates into rehabilitation programs for pediatric burn survivors can contribute positively to physical and functional recovery, potentially improving their overall quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 15, 2023
Est. primary completion date October 22, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 15 Years
Eligibility Inclusion Criteria: Children with lower limb (LL) healed burns. Age between 10 and 15 years. Six months post-injury. Mixed deep 2nd & 3rd degree burn. Total body surface area (TBSA) between 35-55 percent. Capability to walk securely without assistance. Exclusion Criteria: Lower limb joint range of motion limits. Mental illnesses. Significant behavioral or cognitive impairments. Incapacity to exercise. Metabolic diseases. Neuropathy. Visual or vestibular abnormalities. Medical instability.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates exercises
participants underwent a 12-week intervention involving three Pilates sessions per week. The Pilates exercises comprised warm-up activities, Pilates routines, and cool-down exercises.
traditional physical therapy program
The program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy.

Locations

Country Name City State
Saudi Arabia Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University Al-Kharj Riyadh

Sponsors (3)

Lead Sponsor Collaborator
Qassim University Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Aibar-Almazan A, Martinez-Amat A, Cruz-Diaz D, Jesus de la Torre-Cruz M, Jimenez-Garcia JD, Zagalaz-Anula N, Redecillas-Peiro MT, Mendoza-Ladron de Guevara N, Hita-Contreras F. The Influence of Pilates Exercises on Body Composition, Muscle Strength, and Gait Speed in Community-Dwelling Older Women: A Randomized Controlled Trial. J Strength Cond Res. 2022 Aug 1;36(8):2298-2305. doi: 10.1519/JSC.0000000000003790. Epub 2020 Sep 25. — View Citation

Farrell RT, Gamelli RL, Sinacore J. Analysis of functional outcomes in patients discharged from an acute burn center. J Burn Care Res. 2006 Mar-Apr;27(2):189-94. doi: 10.1097/01.BCR.0000202615.59734.0E. — View Citation

Gojowy D, Kauke M, Ohmann T, Homann HH, Mannil L. Early and late-recorded predictors of health-related quality of life of burn patients on long-term follow-up. Burns. 2019 Sep;45(6):1300-1310. doi: 10.1016/j.burns.2019.03.016. Epub 2019 Jun 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Strength Assessment Assessed using a calibrated handheld dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA), participants performed three 5-second contractions for each muscle group. The average score in newtons was calculated for each muscle group. at baseline
Primary Muscle Strength Assessment Assessed using a calibrated handheld dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA), participants performed three 5-second contractions for each muscle group. The average score in newtons was calculated for each muscle group. after 12 weeks
Primary 6-minute walk test Participants were timed and given six minutes to walk as far as they could along a straight course. Running, jumping, or hopping were not allowed. at baseline
Primary 6-minute walk test Participants were timed and given six minutes to walk as far as they could along a straight course. Running, jumping, or hopping were not allowed. after 12 weeks
Secondary Pediatric Quality of Life Inventory A self-report questionnaire assessing the health-related quality of life (HRQL) of children and adolescents. It includes physical health, psychosocial health, and a total summary score. at baseline
Secondary Pediatric Quality of Life Inventory A self-report questionnaire assessing the health-related quality of life (HRQL) of children and adolescents. It includes physical health, psychosocial health, and a total summary score. after 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A