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Burn InjuryNCT07896135

Effects of Hop-Stabilization Training on Postural and Functional Rehabilitation in Children With Lower-Limb Burns

A study testing Progressive Hop-Stabilization Training and Traditional physical therapy in people with Burn Injury and Postural Balance Disorders, run by Qassim University at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Children with severe burns affecting both lower limbs may experience persistent difficulties with balance, walking, and physical function. This randomized controlled trial investigated whether adding progressive hop-stabilization training to standard physical rehabilitation improves postural control, dynamic balance… Read more about this study

Who is it for?
Ages 10 to 17 years
What is being tested?
Progressive Hop-Stabilization Training and Traditional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteSaudi Arabia
Study dates
6 Apr 2026to 17 Oct 2026
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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 10-17 years.
  • Healed deep partial-thickness, full-thickness, or mixed-depth burns involving both lower limbs.
  • Total body surface area (TBSA) affected by burns greater than 30%.
  • At least six months elapsed since hospital discharge.
  • Medically stable and capable of participating in structured exercise rehabilitation.
  • Able to walk independently without assistive devices.
  • Able to understand and safely perform the required exercise and assessment procedures.

Who cannot join

  • Pre-existing neurological or musculoskeletal disorders that could affect balance, gait, or lower-limb performance.
  • Metabolic diseases or peripheral neuropathy that could interfere with functional assessments.
  • Visual or vestibular impairments affecting postural stability.
  • Severe lower-limb contractures or restricted joint mobility that could compromise safe hopping or functional testing.
  • Cognitive or behavioral difficulties that substantially limit understanding of instructions or adherence to study procedures.
  • Concurrent participation in another structured rehabilitation or exercise program that could influence the study outcomes.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Physical Therapy Outpatient Clinic, Prince Sattam bin Abdulaziz University

    Al Kharj, Riyadh Region

Other trials in Saudi Arabia

About this study

Official title: Targeted Postural and Functional Rehabilitation Via Adjunctive Hop-Stabilization Training in Pediatric Lower-Limb Burns: A Randomized Clinical Trial

Children with severe burns affecting both lower limbs may experience persistent difficulties with balance, walking, and physical function. This randomized controlled trial investigated whether adding progressive hop-stabilization training to standard physical rehabilitation improves postural control, dynamic balance, gait, and lower-limb function.

Fifty-four children aged 10-17 years with healed bilateral lower-limb burns were randomly assigned to two groups. Both groups received standard rehabilitation three times weekly for eight weeks, while the experimental group additionally performed supervised hop-stabilization exercises. Postural stability, dynamic balance, walking ability, and lower-limb functional performance were assessed before and immediately after treatment.

Read the detailed description

Children with lower-limb burns may experience persistent limitations in balance, gait, and lower-limb function. Hop-stabilization training provides repeated multidirectional loading, controlled landing, and rapid postural adjustment and may therefore represent a task-specific rehabilitation strategy; however, its effects in pediatric burn rehabilitation remain unclear. This two-arm, parallel-group randomized controlled trial will include 54 children aged 10-17 years with healed bilateral lower-limb burns and total body surface area involvement >30%. Participants will be randomly allocated in a 1:1 ratio to either a hop-stabilization group receiving progressive hop-stabilization training in addition to traditional physical therapy or a control group receiving traditional physical therapy alone. Both groups will receive treatment three times weekly for 8 weeks. The experimental program will include progressive multidirectional hopping and landing-stabilization exercises. Outcomes will be assessed at baseline and after treatment by a blinded examiner.

Being tested
Progressive Hop-Stabilization Training, Traditional physical therapy
Keywords
Burns, Children, Hop-stabilization training, Balance, Gait, Lower-limb function, Rehabilitation
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Hop-Stabilization TrainingOther

    In addition to traditional physical therapy, participants in the experimental group received a progressive hop-stabilization training program three times per week for eight consecutive weeks. The program included side-to-side hopping, forward-and-backward hopping, forward hop-and-stabilization, figure-8 hopping, zigzag hopping, and 4-square hopping. All exercises were performed under the direct supervision of a physiotherapist. Difficulty throughout the program was progressively, verbal feedback was provided throughout the hop-stabilization program to promote appropriate landing biomechanics.

  • Traditional physical therapyOther

    Participants in both groups received a supervised traditional rehabilitative exercise program three times per week for eight consecutive weeks. The program was individualized according to each child's functional status, burn characteristics, and exercise tolerance. Each 50-60-minute session included warm-up, aerobic conditioning, progressive strengthening, functional training, scar management as indicated, and cool-down.

Study groups in NCT07896135
Study groupRoleWhat they receive
Hop-Stabilization Training (HS-TR)ExperimentalParticipants received an eight-week progressive hop-stabilization training program in addition to standard physical rehabilitation. Training was supervised by a physiotherapist and conducted three times weekly.
Receives: Other: Progressive Hop-Stabilization Training; Other: Traditional physical therapy
Standard Physical RehabilitationActive comparatorParticipants underwent supervised standard physical rehabilitation three times weekly for eight weeks.
Receives: Other: Traditional physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postural Stability

    Postural stability and dynamic Limits of Stability (LOS) were assessed using the ProKin System. Across three maximum-effort trials with 60-second rest intervals, the software calculated: Mediolateral Excursion Limit (%), Anteroposterior Excursion Limit (%), Overall Excursion Area (mm2), Directional Control Index, and Trunk Displacement Angle (o), with the mean of three successful trials retained for statistical analysis.

    Measured: Baseline (Pre-Intervention)

  2. Postural Stability

    Postural stability and dynamic Limits of Stability (LOS) were assessed using the ProKin System. Across three maximum-effort trials with 60-second rest intervals, the software calculated: Mediolateral Excursion Limit (%), Anteroposterior Excursion Limit (%), Overall Excursion Area (mm2), Directional Control Index, and Trunk Displacement Angle (o), with the mean of three successful trials retained for statistical analysis.

    Measured: Week 8 (Post-Intervention)

  3. Lower Quarter Y-Balance Test (YBT-LQ)

    Dynamic balance was assessed using the Lower Quarter Y-Balance Test (YBT-LQ). Participants stood on one leg on the central platform and reached as far as possible with the contralateral leg in the anterior (AT), posteromedial (PM), and posterolateral (PL) directions while maintaining balance. The composite score for was calculated as: composite score (%) = [AT + PM + PL maximal reach distances (cm)] / [3 × lower-limb length (cm)] × 100.

    Measured: Baseline (Pre-Intervention)

  4. Lower Quarter Y-Balance Test (YBT-LQ)

    Dynamic balance was assessed using the Lower Quarter Y-Balance Test (YBT-LQ). Participants stood on one leg on the central platform and reached as far as possible with the contralateral leg in the anterior (AT), posteromedial (PM), and posterolateral (PL) directions while maintaining balance. The composite score for was calculated as: composite score (%) = [AT + PM + PL maximal reach distances (cm)] / [3 × lower-limb length (cm)] × 100.

    Measured: Week 8 (Post-Intervention)

Secondary outcomes (8)
  1. Functional Gait Assessment Modified for Children

    Functional gait performance was assessed using the Functional Gait Assessment modified for Children (FGA-mC). The FGA-mC consists of 10-item assessment designed to evaluate higher-level gait performance under progressively challenging conditions. Higher scores indicate better functional gait performance.

    Measured: Baseline (Pre-Intervention)

  2. Functional Gait Assessment Modified for Children

    Functional gait performance was assessed using the Functional Gait Assessment modified for Children (FGA-mC). The FGA-mC consists of 10-item assessment designed to evaluate higher-level gait performance under progressively challenging conditions. Higher scores indicate better functional gait performance.

    Measured: Week 8 (Post-Intervention)

  3. Single Hop for Distance Test

    The Single Hop for Distance Test used to assess unilateral lower-limb functional performance, including forward propulsion and landing control. Hop distance was measured to the nearest 0.5 cm from the starting line to the posterior aspect of the heel at landing. To allow standardized comparisons, absolute hop distance (cm) was normalized to leg length and demonstrated as a percentage.

    Measured: Baseline (Pre-Intervention)

  4. Single Hop for Distance Test

    The Single Hop for Distance Test used to assess unilateral lower-limb functional performance, including forward propulsion and landing control. Hop distance was measured to the nearest 0.5 cm from the starting line to the posterior aspect of the heel at landing. To allow standardized comparisons, absolute hop distance (cm) was normalized to leg length and demonstrated as a percentage.

    Measured: Week 8 (Post-Intervention)

  5. Timed Up and Down Stairs Test

    Timed Up and Down Stairs Test was used to assess functional mobility. the subject was asked to stand 30 cm from the bottom of a 14-step flight of stairs (19.5-cm step height). The test score was the time in seconds from the "go" cue until the second foot returned to the bottom land

    Measured: Baseline (Pre-Intervention)

  6. Timed Up and Down Stairs Test

    Timed Up and Down Stairs Test was used to assess functional mobility. the subject was asked to stand 30 cm from the bottom of a 14-step flight of stairs (19.5-cm step height). The test score was the time in seconds from the "go" cue until the second foot returned to the bottom land

    Measured: Week 8 (Post-Intervention)

  7. Timed One-Legged Stance Test

    The Timed One-Legged Stance test was used to assess single-limb static balance and postural control. Timing began when the no stance foot left the floor and stopped if the participant removed the hands from the hips, looked down, touched the floor with the contralateral foot, or otherwise lost the test position. Performance was recorded in seconds, with longer times indicating better balance ability.

    Measured: Baseline (Pre-Intervention)

  8. Timed One-Legged Stance Test

    The Timed One-Legged Stance test was used to assess single-limb static balance and postural control. Timing began when the no stance foot left the floor and stopped if the participant removed the hands from the hips, looked down, touched the floor with the contralateral foot, or otherwise lost the test position. Performance was recorded in seconds, with longer times indicating better balance ability.

    Measured: Week 8 (Post-Intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start6 Apr 2026
  3. Primary completion15 Oct 2026
  4. Study completion17 Oct 2026

Resources

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
Model description
This two-arm, parallel-group randomized controlled trial included 54 children with bilateral lower-limb burns. Participants were randomly allocated in a 1:1 ratio to either an experimental group receiving progressive hop-stabilization training combined with standard physical rehabilitation or a control group receiving standard rehabilitation alone. Both groups underwent supervised treatment three times weekly for eight consecutive weeks. Outcomes were assessed at baseline and immediately after the intervention by an assessor blinded to group allocation.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896135
Sponsor's protocol ID
RHPT/026/023
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Patel KF, Rodriguez-Mercedes SL, Grant GG, Rencken CA, Kinney EM, Austen A, Hou C, Brady KJS, Schneider JC, Kazis LE, Ryan CM. Physical, Psychological, and Social Outcomes in Pediatric Burn Survivors Ages 5 to 18 Years: A Systematic Review. J Burn Care Res. 2022 Mar 23;43(2):343-352. doi: 10.1093/jbcr/irab225.

    PubMed 34922361
  • Jeschke MG, Herndon DN. Burns in children: standard and new treatments. Lancet. 2014 Mar 29;383(9923):1168-78. doi: 10.1016/S0140-6736(13)61093-4. Epub 2013 Sep 11.

    PubMed 24034453
  • Koljonen V, Laitila M, Rissanen AM, Sintonen H, Roine RP. Treatment of patients with severe burns-costs and health-related quality of life outcome. J Burn Care Res. 2013 Nov-Dec;34(6):e318-25. doi: 10.1097/BCR.0b013e3182779c90.

    PubMed 23702860
  • Santos E, Chacon KL, Shepler LJ, McMullen KA, Slavin MD, van de Rijn M, Kowalske KJ, Ryan CM, Schneider JC. Balance Impairment in the Burn Population: A Burn Model System National Database Study. Eur Burn J. 2024;5(3):238-248. doi: 10.3390/ebj5030023.

    PubMed 39309318
  • Basha MA, Elnaggar RK, Aloraini SM, Alsultan F, Alharbi A, Alqahtani A, El-Keblawy MM, Azab AR, Kamel FH. Trajectories of physical fitness following paediatric burn injury: A two-year longitudinal and predictive analysis. Clin Rehabil. 2026 Jun 16:2692155261459618. doi: 10.1177/02692155261459618. Online ahead of print.

    PubMed 42299688

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Hop-Stabilization Training and Traditional physical therapy in people with Burn Injury and Postural Balance Disorders, run by Qassim University at 1 site in Saudi Arabia.

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 7 inclusion and 6 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 26 Oct 2026. 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 Saudi Arabia. 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?

Postural Stability (time frame: Baseline (Pre-Intervention)). The study lists 4 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 NCT07896135, which also lists 5 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 26 Oct 2026.

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