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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101700353976 Date of Approval: 18/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Visual Biofeedback Training on Postural Instability in Chronic Stroke Patients
Official scientific title Effect of Visual Biofeedback Training on Postural Instability in Chronic Stroke Patients
Brief summary describing the background and objectives of the trial Background: Stroke affects postural stability in approximately 85% of stroke survivors. Postural stability is essential for limb functions. Postural stability training post-stroke remains a challenge because of poor recovery of both motor and sensory function. Objectives: To determine the effect of visual biofeedback training on postural instability in chronic stroke patients.
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
Anticipated trial start date 16/01/2021
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants)
Recruitment status 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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group the selected traditional physical therapy rehabilitation program only Treatment duration was about for eight weeks (12 sessions; three times per weekday after day and each session for 30 min for both groups). Treatment duration was about for eight weeks (12 sessions; three times per weekday after day and each session for 30 min for both groups). 1- Conventional gait training (10 min): as Circuit training (reaching in sitting and standing, sit-to-stand, step-ups, heel lifts, walking over obstacles and up and down slopes).8 2- Balance exercise on balance board (10 min) (Tilt board Balance Training) The subject stands on a tilt board or balance board with both feet on the board. The therapist perturbs the tilt board in forward and backward and side-to-side directions for approximately 30 seconds each.9 3- Diaphragmatic breathing (10 min): is a type of breathing exercise that helps strengthen his diaphragm, an important muscle that helps you breathe as it represents 80% of breathing. The aims of this exercise are to mobilize secretions, teach effective coughing and remove secretions, teach relaxation, teach breathing control, teach postural awareness and mobilize thorax and shoulder girdle.10 Technique: ask patient to - Lie on his back on a flat surface (or in bed) with his knees bent. You can use a pillow under his head and his knees for support if that's more comfortable. - Place one hand on his upper chest and the other on his belly, just below his rib cage. - Breathe in slowly through his nose, letting the air in deeply, towards his lower belly. The hand on his chest should remain still, while the one on his belly should rise. - Tighten his abdominal muscles and let them fall inward as you exhale through pursed lips. The hand on his belly should move down to its original position. 28 Active-Treatment of Control Group
Experimental Group The visual biofeedback training in addiotion to traditional physical therapy eight weeks (24 sessions; three times per week). eight weeks (24 sessions; three times per week). received visual biofeedback training, on Biodex balance system, in addition to the selected traditional physical therapy rehabilitation program. The visual biofeedback training simulates specific movement patterns or strategies by placing markers on specific locations on the screen grid. The platform stability was set to level 8 (more stable). The foot angle for each patient was detected by using the alphanumeric grid on the foot platform (15-20o). All patients were standing on both feet and grasped the handrails. Once the platform had a motion, the patient was instructed to achieve a centered position. The hand support was released gradually, and the patient continued the training without support. The patients attempted to touch targets nine times using an on-screen cursor maneuvered by the subjects’ legs on the device’s platform. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-chronic hemiplegic patients (more than 6 months) -both genders were included (42 males and 14 females) -aged from 40 to 50 years participated in this study. -with mild spasticity (according to Modified Ashwarth scale: appendix II). -Clinically, all patients suffered from postural instability and able to stand with or without assistive device. -The Mini Mental State Examination score >25. -any patient had: -shoulder instability and/or pain -visual impairment -aphasia -unstable cardiovascular disease -other chronic conditions that could interfere with their safety during testing or training procedures Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 50 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 12/11/2020 Ethical Committee of 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, Ad Doqi, Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome overall stability index A pre-measurement before treatment and post-measurement after treatment
Secondary Outcome anterior/posterior stability index A pre-measurement before treatment and post-measurement after treatment
Secondary Outcome medial-lateral stability index A pre-measurement before treatment and post-measurement after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Modern University for Technology and Information Faculty of Physical Therapy El-hadaba El-Wosta, Mokatam, 5th district, Cairo, Egypt. Cairo 19041 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir N Wadee 51 Ebn Fadl Toson Shoubra Cairo 11672 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee 51 Toson st. Shoubra Cairo 11672 Egypt Individual
Secondary Sponsor Ahmed El Shinnawy El-hadaba El-Wosta, Mokatam, 5th district, Cairo, Egypt. Cairo 19041 Egypt Individual
Secondary Sponsor Karim Fathy first 6th October Al Mehwar Al Markazi, Giza Governorate Giza 19966 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee 51 Ebn Fadle Toson Shoubra Cairo 11672 Egypt
Ahmed El Shinnawy El-hadaba El-Wosta, Mokatam, 5th district, Cairo, Egypt. Cairo 19041 Egypt
Karim Fathy First 6th of October, Giza Governorate Cairo 17252 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir N Wadee anazih@cu.edu.eg 01222367919 51 Toson St. Shoubra
City Postal code Country Position/Affiliation
Cairo 11672 Egypt Assistant Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Ahmed El Shinnawy el_shinnawy80@hotmail.com 01092070555 El-hadaba El-Wosta, Mokatam, 5th district, Cairo, Egypt.
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Tamir Fathy amir.nazih@pua.edu.eg 01222367919 First 6th of October, Giza Governorate
City Postal code Country Position/Affiliation
Giza 19969 Egypt Lecturer of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The article delivery approach will go through publishing in an international peer review journal in open access Clinical Study Report,Informed Consent Form 12 months Open access for the document, appendices, consent form, ethical approval and registration approval
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