- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07566442
Frenkel Exercises on Balance and Quality of Life Post Burns
Effect of Frenkel Exercises on Balance and Quality of Life in Patients With Lower Limb Burns
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Introduction: Severe burn injuries to the lower limbs result in reduced muscle strength, postural imbalance, limited walking ability, and diminished functional activities. This research aimed to study the impact of frenkel exercises on balance and quality of life, and determine the most effective treatment program for rehabilitation.
Material and methods: The primary outcome measures were balance, assessed using the Biodex Balance System, and quality of life, evaluated using a validated questionnaire. Secondary outcome measures included lower limb muscle strength, measured by a Lafayette Hand-Held Dynamometer (HHD), and functional ability, assessed using the Lower Extremity Functional Scale (LEFS). Seventy patients of both sexes with thermal burn injuries, aged 25 to 45 years, will participate in this study. The participants will be randomly selected from the Outpatient Clinic of the Faculty of Physical Therapy. They will be randomly assigned into two equal groups, 35 patients each (study group and control group). Group A (Study Group): Patients in this group will receive Frenkel exercises in addition to a traditional physiotherapy program comprising stretching, strengthening exercises and scar management, 3 times a week for 8 weeks. While, Group B (Control Group): Patients in this group will receive traditional physiotherapy program, 3 times a week for 8 weeks.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Research Ethical Committee Faculty of Physical Therapy
- Numer telefonu: 01151312322
- E-mail: eth.com@pt.cu.edu.eg
Kopia zapasowa kontaktu do badania
- Nazwa: yasmeen hamada lotfy mohamed
- Numer telefonu: 01068963069
- E-mail: yasmeen.hamada@pt.cu.edu.eg
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria
- Body mass index (BMI) between 25-30 kg/m²
- Total body surface area (TBSA) 30%-45% determined by rule of nines
- Second-degree thermal burns affecting the lower limbs
- After full wound healing
- Ability to stand and walk independently or with minimal assistance
- Ability to participate in balance training exercises
Exclusion Criteria
- Open wounds in or near the treatment area
- Chemical or electrical burns or inhalation injuries
- Musculoskeletal conditions affecting exercise or testing, or visual/hearing impairments
- Uncontrolled cardiovascular or pulmonary diseases
- Malignant conditions
- Severe behavioral or cognitive disorders
- Uncooperative patients
- Proprioception deficit or balance impairment due to other diseases
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: frenkel exercises
The program was conducted three times per week for eight weeks, with 30-minute sessions performed under visual guidance using slow, controlled, and repetitive movements to enhance coordination and balance.
Exercises progressed from supine (hip, knee, and coordination tasks) to sitting (controlled leg movements and functional transitions), and then to standing activities focusing on static balance (weight shifting, narrow base, tandem stance).
Finally, dynamic balance and gait training were introduced, including forward, sideways, and backward walking.
|
The program was conducted three times per week for eight weeks, with 30-minute sessions performed under visual guidance using slow, controlled, and repetitive movements to enhance coordination and balance.
Exercises progressed from supine (hip, knee, and coordination tasks) to sitting (controlled leg movements and functional transitions), and then to standing activities focusing on static balance (weight shifting, narrow base, tandem stance).
Finally, dynamic balance and gait training were introduced, including forward, sideways, and backward walking.
Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep friction massage, along with skin mobilization techniques. Additionally, customized pressure garments (25-40 mmHg) were used throughout the day, except during hygiene and exercise sessions, with silicone materials applied in areas requiring additional pressure. |
|
Eksperymentalny: Traditional physiotherapy program
Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep friction massage, along with skin mobilization techniques. Additionally, customized pressure garments (25-40 mmHg) were used throughout the day, except during hygiene and exercise sessions, with silicone materials applied in areas requiring additional pressure |
Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep friction massage, along with skin mobilization techniques. Additionally, customized pressure garments (25-40 mmHg) were used throughout the day, except during hygiene and exercise sessions, with silicone materials applied in areas requiring additional pressure. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Berg Balance Scale (BBS)
Ramy czasowe: 8 weeks
|
Balance was evaluated using the 14-item BBS.
This assessment required 10 to 20 minutes for completion and measured the ability of the participant to maintain balance for set periods, both in static positions and during various functional activities.
The total score can range from 0 to 56.
The BBS assesses both static and dynamic balance components
|
8 weeks
|
|
The Short Form 36 (SF-36)
Ramy czasowe: 8 week
|
it was used to assess quality of life.
It is a widely used, validated questionnaire consisting of 36 items that evaluate eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Scores for each domain are transformed to a scale ranging from 0 (worst health status) to 100 (best health status), with higher scores indicating better perceived health.
The eight domains can be further summarized into two main components: the Physical Component Summary (PCS) and the Mental Component Summary
|
8 week
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Timed up and go test
Ramy czasowe: 8 weeks
|
TUG test; used to assess balance and fall risk.
Using a standard chair for the test, the patient is asked to sit on the basis of the chair and stand up and walk with regular steps a predetermined distance of 3 meters in length, then, was asked to walk at walking speed, turn around and sit on the chair again.
The passing time recorded in seconds with a stopwatch
|
8 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: yasmeen hamada lotfy mohamed, Ethical Committee Faculty of Physical Therapy Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 12519939987
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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