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

NCT ID: NCT06010706

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2024-03-01

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.

Detailed Description

Participants will be assigned into two groups:

1. Study group will receive a Supervised physical therapy exercise program in the form of Mobilization exercise, Stretching exercise, and Strengthening exercise.

2. Control group will receive a Home-based exercise program of Stretching exercises, strengthening exercises and ROM exercises.

Conditions

Ankle Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Supervised Manual Physical Therapy 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.

Group Type: EXPERIMENTAL

Supervised physical therapy manual exercise program.

Intervention Type: 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.

Home based exercise program:

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

Group Type: ACTIVE_COMPARATOR

Stretching exercise, ROM, Strengthening exercises.

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jouf University

OTHER

Sponsor Role: lead

Responsible Party

Mosaad

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hadaya Mosaad Eladl

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40046922 (View on PubMed)

Other Identifiers

123456

Identifier Type: -

Identifier Source: org_study_id