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.: PACTR202303862251286 Date of Registration: 09/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Virtual reality versus high intensity interval training on gait and function in chronic stroke patients
Official scientific title Virtual reality versus high intensity interval training on gait and function in chronic stroke patients
Brief summary describing the background and objectives of the trial Maintaining cardiovascular health is the most important strategy for lowering the risk of recurrent stroke , so HIIT may provide an alternative exercise option with the potential to invoke more pronounced cardiovascular and cerebrovascular benefits, but historically, stroke rehabilitation programs provide limited opportunity for cardiovascular training , especially for high-intensity cardiovascular training. The purpose of the current study is to investigate the effect of Virtual Reality using Wii Fit Plus compared to High Intensity Interval Training on aerobic capacity, gait and activities of daily life (ADL) 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 Rehabilitation
Anticipated trial start date 06/03/2023
Actual trial start date
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 39
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group High intensity interval training three times per week for six consecutive weeks HIIT: Each session consisted of 10–15minutes walking on Biodex gait trainer treadmill at moderate intensity (warm-up), followed by 25minutes high-intensity Interval Training and concluded with 5–10minutes walking at light to moderate intensity (cool down). The 25minutes of HIIT comprised four, 4-minute intervals (4 × 4) at 85–95% of Maximum HR or Self-paced interrupted by 3-minute active breaks at 70% of Maximum HR or self-paced. 13
Experimental Group Virtul Reality 3 times per week 6 weeks Virtual Reality Using Wii Fit Plus: Wii Fit Plus training group will perform Wii Fit plus games in form of Basic run and Free run program (jogging in place exercises). These jogging in place exercises(Aerobic exercises) will be chosen from activities software of the Nintendo Wii Fit Plus. The training sessions with Wii fit will be extended up to 25 minutes in addition to 5-10 minutes of warm up and cooling down. The 25minutes of HIIT comprised four, 4-minute intervals (4 × 4) at 85–95% of Maximum HR or Self-paced interrupted by 3-minute active breaks at 70% of Maximum HR or self-paced. 13
Control Group Traditional physical Therapy exercises 3 times per week 6 weeks The standard Physiotherapy involved 30 min of a range of motion exercises, stretching (Hip adductors, knee flexors and ankle planter flexors) for 30 sec. one repetition and active exercises (Hip abductors and flexors + knee flexors + ankle dorsiflexors) of paretic lower limb muscles in supine and sitting positions addressing the soft tissue stiffness, spasticity, muscle inactivity and weakness of the lower limb. Balance training standing (Weight shifting, step standing and single limb support on paretic limb) and gait training according to each patient needs were administered to them for 30 min. duration 13 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patient's age range from 50 to 70 years old. 2- Patients with chronic stroke (more than one year after the disease onset) . 3- Have ability to understand simple verbal commands. 4- Have muscle tone grade 1, 1+ or 2 (Modified Ashworth scale) 5- No botulinum toxin injection in the last 4 months 6- Have Brunstrom stage beyond 3 for lower limb motor recovery were Recruited in the study . The patients were excluded if they have any of the followings: 1- Have any other neurological disorders affecting their lower extremities. 2- Have any previous fracture in lower limb, with metal implant or Pacemaker 3- Are not able to follow directions or present with severe cognitive deficits or Receptive aphasia. 4- Functional surgery in the last six months 5- Recent angina, Heart surgery, or post-covid 19 Aged: 65 Year(s)-79 Year(s) 50 Year(s) 70 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 21/06/2022 Research Ethical committee at Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed El-Zayat St. Dokki giza 12624 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All the spatiotemporal parameters of gait (walking cadence, average step length on the affected and non-affected sides, time on each foot) will be measured at the biodex gait trainer 2 TM system The patients will be assessed pre and post treatment
Primary Outcome Aerobic Capacity by 6 Minute walk test Pre and post treatment
Secondary Outcome Function by Functional independence measure pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out Patientsclinics Faculty of Physical Therapy Cairo University 7 ahmed El-Zayat St. Dokki Giza 12624 Egypt
Al Kasr Al Aini Medical School Al Kasr Al Aini St. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Hadeek Al-ahram , Haram Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahmed El-Zayat St. Dokki Giza 12624 El Salvador University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Fayez dremanfayez_08@yahoo.com +201010961632 Hadeek Al Ahram- Haram
City Postal code Country Position/Affiliation
Giza Egypt Professor of Neurological Rehabilitation Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Yasser Salem Yasser.salem@hofstra.edu +17189260330 128C Hagedorn Hall 119 Hofstra University Hempstead
City Postal code Country Position/Affiliation
New York United States of America Program Director and Professor
Role Name Email Phone Street address
Public Enquiries Wael Shendy w.shendy@pt.cu.edu.eg +201001006711 7 Ahmed El zayat St. Dokki
City Postal code Country Position/Affiliation
Giza Egypt Dean of Faculty of Physical Therapy Port Said University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual Participant Data (IPD) collected during the trial , After deidentification will be shared for research purposes only Informed Consent Form data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Only Researchers in the project can see the data
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