NCT06237361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 23, 2024

Last Update Submit

January 31, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Pediatric Quality of Life Inventory

    at baseline

  • Pediatric Quality of Life Inventory

    after 12 weeks

Study Arms (2)

traditional physical therapy programs

EXPERIMENTAL

group that received traditional physical therapy programs (TPTP) alone

Other: traditional physical therapy program

Pilates group

EXPERIMENTAL

received both traditional physical therapy programs and Pilates exercises.

Other: Pilates exercisesOther: traditional physical therapy program

Interventions

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.

Also known as: Pilates band
Pilates group

The program included a variety of exercises such as range of motion exercises, aerobic exercises, resistance exercises, scar management, occupational therapy, and hand therapy.

Also known as: Exercise
Pilates grouptraditional physical therapy programs

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11432, Saudi Arabia

Location

Related Publications (4)

  • 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.

    PMID: 32991508BACKGROUND
  • 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.

  • 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.

  • Azab AR, Basalem N, Alghadier M, Khanam H, George J, Aloraini SM, Alsultan F, Basha MA, S Waked I, Kamel FH. Muscle Strength, Functional Capacity, and Quality of Life Responses to Pilates Exercises in Children with Burn Injuries: A Single-Blinded Randomized Clinical Trial. Iran J Med Sci. 2025 Nov 1;50(11):743-753. doi: 10.30476/ijms.2025.104947.3852. eCollection 2025 Nov.

MeSH Terms

Conditions

Burns

Interventions

Exercise Movement TechniquesExercise

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alshimaa Azab, PhD

    Professor, Faculty of Physical Therapy, Cairo University

    STUDY CHAIR
  • Maged Basha, PhD

    Qassim University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, College of Medical Rehabilitation, Qassim University

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 1, 2024

Study Start

June 10, 2022

Primary Completion

October 22, 2023

Study Completion

December 15, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations