Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202409748500764 Date of Registration: 02/09/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Automated Plantar Foot Stimulation on Balance and Gait Functions in Patient with Multiple Sclerosis
Official scientific title Effect of Automated Plantar Foot Stimulation on Balance and Gait Performance in Patient with Multiple Sclerosis
Brief summary describing the background and objectives of the trial Background: A major global health care issue that causes considerable morbidity and mortality is multiple sclerosis. Worldwide, an estimated 2.8 million persons (or 35.9 per 100,000 people) are considered to have multiple sclerosis. Since 2013, the prevalence of multiple sclerosis has risen in every continent, while disparities in prevalence estimates still exist. The likelihood of having multiple sclerosis is twice as high in women as in men. Normal gait is impossible in multiple sclerosis patients due to loss of sensory and proprioceptive sense in the sole of the foot, which impairs the trunk and lower limb stability. A poor sense of position and movement makes it harder to stay balanced and walk normally, which limits social interaction. One of the clinical characteristics of multiple sclerosis is impaired balance. .Enhancing the patient's capacity to use sole of the foot receptors to feel body position is crucial. Plantar foot stimulation helps multiple sclerosis patients with their balance, gait, and fall risk. Plantar foot stimulation is utilized to help multiple sclerosis patients live better lives by minimizing gait problems, improving posture, and lowering their risk of falling. Objectives of trial: The goal of this interventional study is to investigate the therapeutic efficacy of Automated Plantar Foot Stimulation on Balance and Gait Performance in Patient With Multiple Sclerosis .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 23/08/2024
Actual trial start date
Anticipated date of last follow up 25/11/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Automated Plantar Foot Stimulation Device 10 minutes of automated plantar foot stimulation device in static position and then a 30 minutes session of therapeutic exercises program for 3 sessions per week three months It comprises left and right foot supports with electric motors that turn on metallic stimulators with round tips measuring 2 by 2 mm in diameter. Four target areas two on each foot, representing the base of the first metatarsal bone between the sesamoid bones and the head of the big toe are stimulated with pressure . pressure ranged from 0.3 to 0.9 N/mm and it was personalized for each patient. The frequency of vibration produced from device range from 50-100 hertz. It will conducted 3 sessions per week for 12 weeks Therapeutic Exercises program This program consists of stretching exercises for foot and lower limb muscles, Graduated active exercise (strengthening exercises, Balance exercises with changes on variables as (eye opening ,stability of the surface, limb movement ,velocity of limb movement), Core stability exercises, Proprioceptive neuromuscular facilitation, Trunk control exercises. 15
Experimental Group Vibrating Insole 10 minutes of Vibrating insole in Dynamic position using treadmill and then a 30 minutes session of therapeutic exercises program for 3 sessions per week Three months A specific foot accessory called a vibrating insole uses mechanical vibrations to deliver therapeutic advantages. The vibration frequency should be adjustable within limits of about 100 hertz (noise signal with varying frequency) . The amplitude of the vibration was set at 90% of the sensory threshold.The width or diameter of the tractors should not exceed 35 mm. Therapeutic Exercises program This program consists of stretching exercises for foot and lower limb muscles, Graduated active exercise (strengthening exercises, Balance exercises with changes on variables as (eye opening ,stability of the surface, limb movement ,velocity of limb movement), Core stability exercises, Proprioceptive neuromuscular facilitation, Trunk control exercises. 15
Control Group Therapeutic Exercises program 30 minutes ,3 times per week Three months The therapeutic exercises program consisted of: • Stretching exercises: For shortened muscles (planter flexors, knee flexors, hip adductors) • Facilitation for weak muscles: Through local facilitatory techniques ( exteroceptors , muscle tapping and muscle activation (isometric, eccentric and concentric contraction) for (hip flexors, hip abductors, knee flexors, ankle dorsiflexors). • Strengthening exercise: For muscles have grade "three" or above in power. It was repeated according to ability of each patient • Proprioceptive Neuromuscular Facilitation Approach: "Flexion, abduction, internal rotation with flexed knee" pattern for lower extremity. The started position was extension, adduction, and internal rotation. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Forty-five multiple sclerosis patients from both sexes will participate in this study. 2) Their BMI ranges between 18.5 and 24.9. 3) Age of patient range from 25-45 years old . 4) Clinically definite Ataxic Multiple Sclerosis (relapsing and remitting) patients who are stable for at least three months 5) Duration of illness started “one" to "two" years ago. 6) Duration of immune regulatory therapy " one" to "two" years. 7) Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24) . 8) Ambulant patients with Expanded disability status scale of each patient ranged between 1.0 and4.5 1) Any other neurological deficits or orthopedics abnormalities such as contracture or deformities. 2) Any other inflammatory or infectious diseases, in the previous month e.g., arthritis. 3) Pregnant patients. 4) Cardiovascular and Pulmonary diseases. 5) Patients in acute relapse stage. 6) Patients with any psychiatric disease. Adult: 18 Year(s)-44 Year(s) 25 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/12/2022 Faculty of Physical Therapy Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi, Al Giza, Giza Governorate Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Changes in step length from baseline to 12 weeks after the beginning of intervention 2D gait analysis for assessment 12 weeks after the beginning of the intervention
Primary Outcome Changes in Angle of dorsiflexion from baseline to 12 weeks after the beginning of intervention 2D gait analysis for assessment 12 weeks after the beginning of the intervention
Primary Outcome Changes in step Time from baseline to 12 weeks after the beginning of intervention 2D gait analysis for assessment 12 weeks after the beginning of the intervention
Secondary Outcome Changes in Overall stability index from baseline to 12 weeks after the beginning of intervention Biodex balance system for assessment 12 weeks after the beginning of the intervention
Secondary Outcome Changes in Antero-posterior stability index from baseline to 12 weeks after the beginning of intervention biodex balance system for assessment 12 weeks after the beginning of the intervention
Secondary Outcome Changes in Medio-lateral stability index from baseline to 12 weeks after the beginning of intervention biodex balance system for assessment 12 weeks after the beginning of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy labs at Cairo University Giza Cairo 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Giza Street Cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo university Giza Cairo 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Tarek Emam mohamedtarekemam@pt.cu.edu.eg 0201060653336 5Th settlement
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Moshera Darwish dr.moshera11@yahoo.com 0201015163617 Dokki
City Postal code Country Position/Affiliation
Cairo Egypt Professor
Role Name Email Phone Street address
Public Enquiries Mohamed Emam mohamedtarekemam@pt.cu.edu.eg 0201060653336 5Th settlement
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through the study may be provided to qualified researchers with academic interest in neurological rehabilitation. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Summary results or a link to summary results within the trial registration record will be done within 12 months of the study completion date. Informed Consent Form The study will be conducted within 3 months and will be availiable within one year Open Access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information