Ankle DeformityNCT06010706
Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents.
A study testing Supervised physical therapy manual exercise program. and Stretching exercise, ROM, Strengthening exercises. in people with Ankle Deformity, run by Jouf University at 1 site in Egypt.
Trial summary
Every year more than 50 million people worldwide are injured due to RTAs which in turn makes it one of the leading causes of disability. During automobile collisions, the lower limbs are the most commonly injured region of the human body. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ankle Deformity
- What is being tested?
- Supervised physical therapy manual exercise program. and Stretching exercise, ROM, Strengthening exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Stable ankle fractures after motor vehicle accidents involving the distal tibia, distal fibula, or talus treated with cast immobilization, with the removed cast in the preceding seven days.
- Approval from the orthopedic specialist to weight-bear as tolerated or partial weight-bear. -- Their ages will be between the age of 18 to 50 years of age.
- Participants having no concurrent injuries or pathology, such as neurological injury or other fractures.
Who cannot join
- Patients with surgical fixation,
- Fracture malunion or nonunion,
- Syndesmosis injury, or any standard contraindication to manual physical therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents, Randomized Controlled Trial.
Every year more than 50 million people worldwide are injured due to RTAs which in turn makes it one of the leading causes of disability. During automobile collisions, the lower limbs are the most commonly injured region of the human body. Ankle injuries can be particularly long-lasting, resulting in excessive medical costs, inability to work, and serious psychological distress. Physiotherapists often contribute to the rehabilitation of ankle fractures, which typically starts soon after the period of immobilization. Joint mobilization led to increased ankle movement, improved gait patterns, reduced pain and the number of treatment sessions required, and hastened return to activities when compared with the usual rest, ice, compression, and elevation protocol.
Read the detailed description
Participants will be assigned into two groups:
- Study group will receive a Supervised physical therapy exercise program in the form of Mobilization exercise, Stretching exercise, and Strengthening exercise.
- Control group will receive a Home-based exercise program of Stretching exercises, strengthening exercises and ROM exercises.
- Conditions
- Ankle Deformity
- Being tested
- Supervised physical therapy manual exercise program., Stretching exercise, ROM, Strengthening exercises.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised physical therapy manual exercise program.Other
- Mobilization Techniques : The joint mobilization technique will be the anterior-posterior glide of the talus. The participant will be positioned in supine or long sitting.
- Stretching Exercise: Passive stretching with therapist assistance was used for ankle dorsiflexion with the knee both flexed and extended. Force during passive stretching was modified to patient tolerance. Each participant flexed the knee slightly while standing on a 10° incline board. The participant was asked to slightly flex both knees until a stretch was felt in the calf muscle.
- Strengthening Exercise:
The resistance training protocol will be based on the progressive resistance training principle and was a modification of the protocol used by Frontera et al [10] in older men. Plantar-flexion resistance training will be performed on a customized hydraulic apparatus, which provide a constant resistance over the entire ROM and allow for concentric as well as eccentric.
Stretching exercise, ROM, Strengthening exercises.Other
Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Manual Physical Therapy Program | Experimental | Participants will receive a supervised physical therapy program including: mobilizing exercises, stretching exercises, and strengthening exercises. 3 sessions a week for eight consecutive weeks. Receives: Other: Supervised physical therapy manual exercise program. |
| Home based exercise program: | Active comparator | Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance. The home-based program will include stretching, ROM and strengthening exercises Receives: Other: Stretching exercise, ROM, Strengthening exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. EMG assessment of muscle activity:
Electromyogram (EMG) is the recording of the muscle activity and in this study EMG will be recorded from the tibialis anterior (TA) and the triceps surae muscle groups: medial gastrocnemius (MG), lateral gastrocnemius (LG) and soleus (SOL). Myomonitor 4 (Delsys, Boston) EMG data acquisition system was used. This has a gain of 1000, CMRR of 92 dB and bandwidth of 20-450 Hz, and 12 dB/octave roll-off. The sampling rate was 1000 Hz with a resolution of 16 bits/sample. Delsys single-channel active differential silver bar (10 mm x 1 mm) were used to record EMG. These will be embedded preamplifiers and fixed inter-electrode distance of 10 mm.
Measured: 2 momths
Secondary outcomes (4)
Dynamic Plantar Pressure
Dynamic plantar pressure was recorded using a single BTS P-WALK pressure platform (BTS Bioengineering S.p.A. Italy), with dimensions 640 mm _ 740 mm _ 8 mm and an acquisition frequency of 250 Hz. Data transmission to the computer is via USB2, where specific software (BTS G-Studio) processes the information received. The software itself identifies each step performed, and in the processing, the researchers themselves (M.F.-G. and D.S.-G.) take care of eliminating incorrect or incomplete steps .
For data collection, the pressure platform was placed in the intermediate part (4 m) of the walkway. In this way, for step standardization, we ensured that at least three steps were taken before stepping on the plate. Five steps were collected with each limb during a continuous gait cycle. The variables recorded using the pressure platform were: weight-normalised peak plantar pressure (PPP) (kPa)-peak pressure recorded from the total number of steps taken during the gait.
Measured: 2 months.
Berg Balance Scale (BBS):
The Berg balance scale includes 14 items with scores from 0 to 4. A score of 0 represents the inability to do the task, while a score of 4 represents the ability to do the task completely, according to the assigned criteria, with 56 indicates the total score. Items range from tasks of simple mobility (e.g. transfers, standing unsupported, sit-to-stand) to tasks with greater difficulty.
Measured: 2 months.
Ankle Joint Dorsiflexion and Planterflexion Range (ROM):
Passive ankle-dorsiflexion and planterflexion ROM will be measured in 2 positions (extended knee and flexed knee) using a standard manual goniometer. For the extended-knee assessment, Patients will be seated on a treatment table with the knees fully extended (0°) and the feet hanging off the end of the table. For the flexed-knee assessment, they will be seated with the popliteal space at the edge of the table and the knees in 90° of flexion. For each ROM measurement, the participant will be completely relaxed; the investigator will passively moved the ankle into dorsiflexion and planterflexion from a neutral starting position (ie, 90° angle between shank and foot segments) until a firm end feel will be elicited. The axis of the goniometer will be centered over the lateral malleolus and the arms will be aligned with the fibular shaft and the head of the fifth metatarsal.
Measured: 2 months.
Pain Assessment.
By numerical rating scale: The 11-point numerical pain rating scale was used in this study to indicate the intensity pain. It is composed of a numeric segmented horizontal line ranging from 0 which represents "no pain" and 10 which represents "worst imaginable pain." The scale was explained to each participant before using to ensure efficiency. Each participant was instructed to choose a numerical value (from 0 to 10 integers) that best describes the intensity of his pain in the preceding 24 hours.
Measured: 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start25 Aug 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosaad, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010706
- Sponsor's protocol ID
- 123456
- Status last verified
- Apr 2024
- First submitted
- 20 Aug 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after 6 months of publication.
Publications
Eladl HM, Elsherbini DMA, Elshorbagy RT, Ibrahim AM, El-Sherbiny M, Ibrahim SEAE, Elfayoumi GIF, Aboonq MS, Elbastawisy YM, Salama MEM, Allam NM. Efficacy of adding mobilization and balance exercises to a home-based exercise program in patients with ankle disability: a randomized controlled trial. Front Med (Lausanne). 2025 Feb 19;12:1512587. doi: 10.3389/fmed.2025.1512587. eCollection 2025.
PubMed 40046922
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06010706
- Acronym / sponsor ID
- 123456
- Conditions
- Ankle Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Every year more than 50 million people worldwide are injured due to RTAs which in turn makes it one of the leading causes of disability. During automobile collisions, the lower limbs are the most commonly injured region of the human body. Ankle injuries can be particularly long-lasting, resulting in excessive medical costs, inability to work, and serious psychological distress. Physiotherapists often contribute to the rehabilitation of ankle fractures, which typically starts soon after the period of immobilization. Joint mobilization led to increased ankle movement, improved gait patterns, reduced pain and the number of treatment sessions required, and hastened return to activities when compared with the usual rest, ice, compression, and elevation protocol.
Detailed description
Participants will be assigned into two groups:
- Study group will receive a Supervised physical therapy exercise program in the form of Mobilization exercise, Stretching exercise, and Strengthening exercise.
- Control group will receive a Home-based exercise program of Stretching exercises, strengthening exercises and ROM exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Manual Physical Therapy Program | Experimental | Other: Supervised physical therapy manual exercise program.Participants will receive a supervised physical therapy program including: mobilizing exercises, stretching exercises, and strengthening exercises. 3 sessions a week for eight consecutive weeks. |
| Home based exercise program: | Active comparator | Other: Stretching exercise, ROM, Strengthening exercises.Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance. The home-based program will include stretching, ROM and strengthening exercises |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with Stable ankle fractures after motor vehicle accidents involving the distal tibia, distal fibula, or talus treated with cast immobilization, with the removed cast in the preceding seven days.
- Approval from the orthopedic specialist to weight-bear as tolerated or partial weight-bear. -- Their ages will be between the age of 18 to 50 years of age.
- Participants having no concurrent injuries or pathology, such as neurological injury or other fractures.
Key exclusion criteria (3 listed)
- Patients with surgical fixation,
- Fracture malunion or nonunion,
- Syndesmosis injury, or any standard contraindication to manual physical therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised physical therapy manual exercise program.1. Mobilization Techniques : The joint mobilization technique will be the anterior-posterior glide of the talus. The participant will be positioned in supine or long sitting. 2. Stretching Exercise: Passive stretching with therapist assistance was used for ankle dorsiflexion with the knee both flexed and extended. Force during passive stretching was modified to patient tolerance. Each participant flexed the knee slightly while standing on a 10° incline board. The participant was asked to slightly flex both knees until a stretch was felt in the calf muscle. 3. Strengthening Exercise: The resistance training protocol will be based on the progressive resistance training principle and was a modification of the protocol used by Frontera et al [10] in older men. Plantar-flexion resistance training will be performed on a customized hydraulic apparatus, which provide a constant resistance over the entire ROM and allow for concentric as well as eccentric. | Other | Supervised Manual Physical Therapy Program |
| Stretching exercise, ROM, Strengthening exercises.Patients at the control group will receive instruction for home based exercise program of physical therapy exercise. The home program primarily consisted of exercises targeting deficits in joint ROM, muscle flexibility and strength, and balance. | Other | Home based exercise program: |
Primary outcome
1. EMG assessment of muscle activity:
Time frame: 2 momths
Electromyogram (EMG) is the recording of the muscle activity and in this study EMG will be recorded from the tibialis anterior (TA) and the triceps surae muscle groups: medial gastrocnemius (MG), lateral gastrocnemius (LG) and soleus (SOL). Myomonitor 4 (Delsys, Boston) EMG data acquisition system was used. This has a gain of 1000, CMRR of 92 dB and bandwidth of 20-450 Hz, and 12 dB/octave roll-off. The sampling rate was 1000 Hz with a resolution of 16 bits/sample. Delsys single-channel active differential silver bar (10 mm x 1 mm) were used to record EMG. These will be embedded preamplifiers and fixed inter-electrode distance of 10 mm.
4 secondary outcomes
Dynamic Plantar Pressure
Time frame: 2 months.
Berg Balance Scale (BBS):
Time frame: 2 months.
Ankle Joint Dorsiflexion and Planterflexion Range (ROM):
Time frame: 2 months.
Pain Assessment.
Time frame: 2 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 40046922Eladl HM, Elsherbini DMA, Elshorbagy RT, Ibrahim AM, El-Sherbiny M, Ibrahim SEAE, Elfayoumi GIF, Aboonq MS, Elbastawisy YM, Salama MEM, Allam NM. Efficacy of adding mobilization and balance exercises to a home-based exercise program in patients with ankle disability: a randomized controlled trial. Front Med (Lausanne). 2025 Feb 19;12:1512587. doi: 10.3389/fmed.2025.1512587. eCollection 2025.
- Individual participant dataSharing planned: Yes. Data will be shared after 6 months of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised physical therapy manual exercise program. and Stretching exercise, ROM, Strengthening exercises. in people with Ankle Deformity, run by Jouf University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. EMG assessment of muscle activity: (time frame: 2 momths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024; AzTrials last refreshed its copy on 29 Oct 2026.