NCT05991479

Brief Summary

The study will be carried out on 76 patients suffering from lower limb burns with TBSA ranging from 30% to 40%. The patients will be subdivided into two groups of equal number. Group (A): (The study group) who will receive Pilates exercise in addition to traditional physical therapy programme in the form of stretching and strengthening exercises and deep friction massage for scar management. Group (B): (The control group) who will receive traditional physical therapy programme only.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

August 6, 2023

Last Update Submit

May 28, 2024

Conditions

Keywords

Pilates exercisesMuscle strengthBalanceLower limb burns

Outcome Measures

Primary Outcomes (2)

  • Lafayette hand-held dynamometer:

    The maximum isometric force of knee flexors and extensors will be measured before and after treatment period using Lafayette HHD. The MIF will be measured through an accommodating isometric "make" test, where participants applied maximal force against the examiner while a steady position was maintained. Participants will perform three, 5 seconds contractions for each muscle group with a 30 second rest after each trial and 5 minutes rest between muscle groups. The average force of the three testing trials will be computed for each muscle. The examiner encourages participants to do their best effort during measurement. Knee extensors and flexors are assessed while participants are in a sitting position, hips and knees 90° flexed. The dynamometer is positioned above the ankle joint, on the anterior aspect of the shank for assessing knee extensors, or on the posterior aspect of the shank for measuring knee flexors.

    8 weeks

  • Berg balance scale:

    it consists of 14 items representing functional movements common in everyday life. Some items require that the patient maintain positions of increasing difficulty, from sitting to standing on one leg. Other items evaluate the ability to perform specific tasks, such as reaching forward, turning around and picking up an object from the floor. Scoring is based on the ability to meet certain time or distance requirements and to perform the items independently. Each task is scored on a 5-point scale from 0 to 4, giving a maximum score of 56, which indicates balance ability within the normal range.

    8 weeks

Secondary Outcomes (1)

  • Arabic version of Lower extremity functional scale

    8 weeks

Study Arms (2)

(Pilates exercises plus traditional physical therapy programme)

EXPERIMENTAL

Pilates exercises: The Pilates training protocol will take 60 min per session, including 10 min of warm up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for cool down. The number of repetitions will be 10 times. The patient will perform the following Pilates exercises: (Hundred exercises, spine stretch, single leg stretch , double leg stretch, criss cross, swimming, one leg kick, side kick, clam, one leg circle, shoulder bridge, hip twist, roll up and down and standing footwork).Pilates training (3 sessions/week) for 8 weeks. traditional physical therapy programme: consisting of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include: 1. Stretching exercises for calf and hamstring muscles. 2. Strengthening exercises for hip, knee, ankle, and foot muscles. 3. Deep friction massage for scar management:

Other: Pilates exercisesOther: Traditional physical therapy programme:

(traditional physical therapy programme)

EXPERIMENTAL

All patients will receive a traditional physical therapy programme consisting of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include: 1. Stretching exercises for calf and hamstring muscles. 2. Strengthening exercises for hip, knee, ankle, and foot muscles. 3. Deep friction massage for scar management:

Other: Traditional physical therapy programme:

Interventions

Pilates exercises: The subjects will receive Pilates training (3 sessions/week) for 8 weeks. The Pilates training protocol will take 60 min per session, including 10 min of warm up prior to initiating the Pilates technique, 40 min for Pilates exercises and 10 min for cool down. The number of repetitions will be 10 times. The patient will perform the following Pilates exercises: (Hundred exercises, spine stretch, single leg stretch , double leg stretch, criss cross, swimming, one leg kick, side kick, clam, one leg circle, shoulder bridge, hip twist, roll up and down and standing footwork).

(Pilates exercises plus traditional physical therapy programme)

All patients will receive a traditional physical therapy programme consisting of 45 minutes per session of a supervised and individualized exercise programme for three sessions per week for eight weeks which will include: Stretching exercises for calf and hamstring muscles. Strengthening exercises for hip, knee, ankle, and foot muscles. Deep friction massage for scar management.

(Pilates exercises plus traditional physical therapy programme)(traditional physical therapy programme)

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients were chosen under the following criteria:
  • Patients of both genders participated in this study.
  • The patients' age ranged from 20-40 years old.
  • Patients with lower limb second degree burn (partial thickness of thermal injury).
  • Total burned surface area (TBSA) ranged from 30% to 40% measured by the rule of nine.
  • Patients began the training programme after complete wound healing.

You may not qualify if:

  • The current study excluded the following patients:
  • Patients with an open wound at or near the treatment site.
  • Patients with chemical or electrical burns.
  • Patients with inhalation injury.
  • Patients with any limitation in lower limb range of motion.
  • Patients with musculoskeletal disorders or deformities that would impair performance during training and tests.
  • Patients with visual or auditory disorders.
  • Patients with neurological disorders.
  • Patients with psychiatric illness, severe behavior or cognitive disorders.
  • Uncooperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Giza, 12613, Egypt

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • yasmeen hamada

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at Department of Surgery and Burn - Faculty of Physical Therapy - Cairo University

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

July 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations