NCT07566442

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

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

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 20, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Frenkel exercises - Balance- Quality of Life - Burns.

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    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)

    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

Secondary Outcomes (1)

  • Timed up and go test

    8 weeks

Study Arms (2)

frenkel exercises

EXPERIMENTAL

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.

Other: frenkel exercisesOther: traditional physical therapy programme

Traditional physiotherapy program

EXPERIMENTAL

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

Other: traditional physical therapy programme

Interventions

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.

frenkel exercises

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.

Traditional physiotherapy programfrenkel exercises

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • with a body mass index (BMI) ranging between 25 and 30 kg/m², a total body surface area (TBSA) of 30% to 45% determined by rule of nines, and having experienced second-degree thermal burns (partial thickness burns) affecting the lower limbs. after full wound healing. Patients were required to be able to stand and walk independently or with minimal assistance and to safely participate in balance training exercises.

You may not qualify if:

  • Patients were excluded if they had open wounds in or adjacent to the treatment areas, chemical or electrical burns, inhalation injuries, musculoskeletal conditions that would impact outcomes during exercises and testing, sight or hearing impairments, uncontrolled cardiovascular or pulmonary diseases, malignant conditions, psychiatric illness, severe behavior or cognitive disorders, uncooperative patients, pregnancy, subjects with a proprioception deficit and impaired balance due to other diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • yasmeen hamada lotfy mohamed

    Ethical Committee Faculty of Physical Therapy Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yasmeen hamada lotfy mohamed

CONTACT

Research Ethical Committee Faculty of Physical Therapy

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 12, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share