Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents.
Efficacy of Supervised Manual Physical Therapy Exercise for Ankle Disability After Motor Vehicle Accidents, Randomized Controlled Trial.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Hadaya M Eladl, PhD
- Phone Number: +201144814304
- Email: hd_mos@yahoo.com
Study Locations
-
-
-
Cairo, Egypt, 12322
- Hadaya Mosaad Eladl
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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.
|
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. |
|
Active Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 momths
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Plantar Pressure
Time Frame: 2 months.
|
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. |
2 months.
|
|
Berg Balance Scale (BBS):
Time Frame: 2 months.
|
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.
|
2 months.
|
|
Ankle Joint Dorsiflexion and Planterflexion Range (ROM):
Time Frame: 2 months.
|
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.
|
2 months.
|
|
Pain Assessment.
Time Frame: 2 months.
|
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.
|
2 months.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 123456 (Innovate UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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