NCT06718829

Brief Summary

The purpose of the study is to determine the effect of core stability and sensorimotor training exercises on postural stability post lower limb burn.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 2, 2024

Last Update Submit

December 2, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • overall stability index

    It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.

    8 weeks

  • anterior-posterior stability index

    It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.

    8 weeks

  • medial-lateral stability index

    It was evaluated using the Biodex Balance System (BBS) before and after the eight-week treatment program. Patients will stand barefoot on the locked platform, centering themselves using visual feedback on the screen. Once stable, foot angles and heel coordinates will be recorded, and tests will commence with stability levels gradually decreasing from level eight to level four. Each test will last 30 seconds, with patients maintaining the cursor within the smallest balance zones. Postural stability measures will be calculated as the mean of three trials.

    8 weeks

Study Arms (3)

Core Stability Exercises + Traditional physical therapy program

EXPERIMENTAL

This group will be composed of 30 patients with lower limb burns. Patients will receive core stability exercises in addition to a traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Other: Core Stability ExercisesOther: Traditional physical therapy program

Sensorimotor Training Exercises + Traditional physical therapy program

EXPERIMENTAL

This group will be composed of 30 patients with lower limb burns. Patients will receive sensorimotor training exercise in addition to traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Other: Sensorimotor Training ExercisesOther: Traditional physical therapy program

Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy program

EXPERIMENTAL

This group will be composed of 30 patients with lower limb burns. Patients will receive core stability exercises and sensorimotor training exercise in addition to traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Other: Core Stability ExercisesOther: Sensorimotor Training ExercisesOther: Traditional physical therapy program

Interventions

Patients will perform core stability exercises three times weekly for eight weeks. The exercises include abdominal hollowing, bridge, right-angle leg lifts with thigh press, seated twist, knee-to-chest with elbow flexion, prone abdominal hollowing, prone arm and leg lift, quadruped abdominal hollowing, quadruped arm or arm-leg lifts, and various plank positions: forearm plank, side plank, forearm plank with hip raise, and forearm plank with straight legs.

Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy programCore Stability Exercises + Traditional physical therapy program

Patients will perform sensorimotor training exercises three times weekly for eight weeks, progressing through three phases: static (weeks 1-2), dynamic (weeks 3-4), and functional (weeks 5-8). Exercises, repeated 3-5 times per session with rest intervals, advance from simple to complex as patients master each level. Static exercises include standing on firm/soft surfaces and single-leg balances. Dynamic exercises add forward lunges and T-band kicks. Functional training incorporates walking on various surfaces, toe and heel skipping, squats, balance drills on wobble boards, and multidirectional rolling movements with visual and single-leg variations. This progression enhances coordination, balance, and functional stability.

Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy programSensorimotor Training Exercises + Traditional physical therapy program

All patients will undergo a traditional physical therapy program consisting of stretching exercises, strengthening exercises, and scar management techniques, three times weekly for eight weeks.

Core Stability Exercises + Sensorimotor Training Exercises + Traditional physical therapy programCore Stability Exercises + Traditional physical therapy programSensorimotor Training Exercises + Traditional physical therapy program

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients are both males and females.
  • Their age will range from (20-50) years.
  • Patients will suffer from lower limb second degree burn (Partial thickness of thermal injury).
  • Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
  • Patients will begin the training program after complete wound healing.
  • Patients will be given their informed consent.

You may not qualify if:

  • Patients who had an open wound at or near treatment site.
  • Patients who had chemical or electrical burn.
  • Musculoskeletal disorders that will impair performance during training and tests.
  • Uncontrolled cardiovascular or pulmonary diseases .
  • Neurological and renal disorders.
  • Metabolic or vascular disease with a neurological component such as diabetes.
  • Malignant conditions.
  • Psychiatric illness, severe behavior or cognitive disorders.
  • Uncooperative patients.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Haidy Nady Ashem, PhD

    Professor, Cairo university

    STUDY CHAIR

Central Study Contacts

Rofaida Mohie Eldeen Ali Sobh, M.Sc

CONTACT

Khadra Mohamed Ali, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2024

First Posted

December 5, 2024

Study Start

December 10, 2024

Primary Completion

May 10, 2025

Study Completion

May 25, 2025

Last Updated

December 5, 2024

Record last verified: 2024-12

Locations