Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents.

NCT06010706 | Completed DMC

• 1 other identifier: 123456
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ankle Deformity

Outcome Measures

Primary Outcomes (1)

• 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.

  2 momths

Secondary Outcomes (4)

• Dynamic Plantar Pressure

  2 months.

• Berg Balance Scale (BBS):

  2 months.

• Ankle Joint Dorsiflexion and Planterflexion Range (ROM):

  2 months.

• Pain Assessment.

  2 months.

Study Arms (2)

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.

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

Other: Stretching exercise, ROM, Strengthening exercises.

Interventions

Supervised physical therapy manual exercise program. OTHER

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.

Supervised Manual Physical Therapy Program

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.

Home based exercise program:

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with surgical fixation,
• Fracture malunion or nonunion,
• Syndesmosis injury, or any standard contraindication to manual physical therapy.

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

Hadaya Mosaad Eladl

Cairo, 12322, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40046922 DERIVED

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: Principal investigator, PhD , Department of physical therapy and Health Rehabilitation, College of applied medical sciences, Jouf University.

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: August 25, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 Months after publication.
• Access Criteria: The study protocol and Informed Consent form will be shared after 6 months of publication.

Locations

EG (1)