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NCT Number: NCT07566442

Frenkel Exercises on Balance and Quality of Life Post Burns

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.

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

frenkel exercises

Other

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.

Traditional physical therapy programme

Other

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.

Primary outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 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

  2. The Short Form 36 (SF-36)

    Time frame: 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

Secondary outcomes

  1. Timed up and go test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Frenkel Exercises on Balance and Quality of Life in Patients With Lower Limb Burns

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 5, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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