Pilates Exercises on Muscle Strength and Balance After Healed Lower Limb Burns
Effect of Pilates Exercises on Muscle Strength and Balance After Healed Lower Limb Burns
1 other identifier
interventional
76
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
August 6, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 29, 2024
May 1, 2024
8 months
August 6, 2023
May 28, 2024
Conditions
Keywords
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)
EXPERIMENTALPilates 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:
(traditional physical therapy programme)
EXPERIMENTALAll 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:
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).
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.
Eligibility Criteria
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
- Cairo Universitylead
Study Sites (1)
Faculty of physical therapy
Giza, 12613, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yasmeen hamada
Cairo University
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