Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202004615444778 Date of Approval: 20/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Exercises on Balance in Multiple Sclerosis
Official scientific title Effect of Physical Therapy Interventions on Balance in Ataxic Multiple Sclerosis Patients
Brief summary describing the background and objectives of the trial Multiple sclerosis (MS) is a common, complex neurological disease. Balance disorders (BDs) and ataxic symptoms are the most frequent and challenging symptoms in MS, lead to abnormal postural stability which has adverse effects on patient's independence, participation, and quality of life. Aim of Study: To investigate the effect of physical therapy interventions on static and dynamic balance in ataxic MS patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MS
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 01/05/2018
Actual trial start date 01/07/2018
Anticipated date of last follow up 01/01/2019
Actual Last follow-up date 01/03/2019
Anticipated target sample size (number of participants) 5
Actual target sample size (number of participants) 5
Recruitment status Completed
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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Core stability training six consecutive weeks, two sessions per week 20 to 25 min. of conventional rehabilitation, five min. of rest 25 to 30 min. of core stability exercises bridging exercises on both lower limbs with a stable surface, bridging exercises on one limb and bridging exercises on an unstable surface, quadruped position exercises with alternative arms and legs raise on a stable and unstable surface 15
Experimental Group task oriented training program six consecutive weeks, two sessions per week 20 to 25 min. of conventional rehabilitation, then five min rest followed by, 30 min. of the task-oriented training program with "five" min. rest in between. sit to stand exercises from various chair height and Swiss ball, standing from a chair, walk a distance and then return, reaching exercises from standing and walking side and forward over obstacles 15
Control Group conventional therapeutic physical therapy program for balance disorders. six consecutive weeks, two sessions per week 50-60 min static postural control, weight shifting and perturbations exercises stretching exercises, active lower limb joint mobilization at the beginning of the session 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients were included with relapsing-remitting MS recruited according to McDonald's criteria 2010. age ranged from 20 to 45 years. Expanded disability scale (EDSS) scores ranged from 2 to 4.5 with ataxic symptoms. The last attack occurred at least two months before recruitment in the study. all of the patients were ambulant with a mild and moderate degree of balance impairment (Berg Balance scale score ranged from 31 to 50) can maintain independent static standing balance with the eye open for five min without assistive device. Patients with other neurological disease or orthopedic deformities which may affect their balance. patients with cardiovascular and pulmonary diseases that make exercise unsafe. patients with cognitive impairment or psychiatric disorders. Pregnant patients patients participated in other regular balance training program was excluded Adult: 19 Year-44 Year 20 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 06/05/2018 Faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - , Giza District, 11432, Egypt Dokki - Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Biodex balance system berg balance scale at the begining of the study and at the end of the study
Secondary Outcome Functional reach test at the begining of the study and at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy cairo university El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432, Egypt Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Habiba Soubhy Rasat elgomharia street , 1797, 2nd district 6 th october.Giza 12563 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Habiba Soubhy rasat elgomharia street , 1797, 2nd district Giza 12563 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Habiba Soubhy Habiba_future@yahoo.com 00201061209505 rasat elgomharia street , 1797, 2nd district
City Postal code Country Position/Affiliation
6 th october 12563 Egypt Habiba Z. Soubhy
Role Name Email Phone Street address
Public Enquiries Ahmed Ali dr.shawky_2011@yahoo.com 00201068443366 Mohamed Elmohsan st, 1687, 4th district
City Postal code Country Position/Affiliation
6th octoberGiza 12563 Egypt Lecture at physical therapy cairo university Ahmed S.Ali
Role Name Email Phone Street address
Scientific Enquiries Moshera Darwish dr.moshera11@yahoo.com 00201015163617 46 soliman gohar - Dokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Moshira H. Darwish
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes One hundred and four patients with remitting and relapsing MS from both sexes were assessed for eligibility. Forty eight patients were excluded from the study as thirty-four patients not meeting the inclusion criteria, "eight" patients decline to participate and "six" patients failed to attend the baseline assessment. Fifty-six patients were randomized and allocated in the study. The patients were selected from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University. Statistical Analysis Plan 2 years controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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