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.: PACTR202404814479865 Date of Approval: 24/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of additional squat training among stroke patients: a randomized controlled trial
Official scientific title Effects of additional squat training on lower limb extremity motor function, balance, ambulation and quality of life among stroke patients: a randomized controlled trial
Brief summary describing the background and objectives of the trial Stroke patients have impaired lower extremity motor function, walk slowly and fall down frequently due to loss of balance. The objectives of the study is to compare the effect of additional squat training to general physical therapy and general physical therapy alone on lower extremity motor function, balance, ambulation and quality of life among 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 28/03/2022
Actual trial start date 07/08/2023
Anticipated date of last follow up 10/05/2024
Actual Last follow-up date 17/05/2024
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 48
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Squat training Squat training will be administered three times a week for 8 weeks 8 weeks Squat training and general physical therapy (activities involving squat and general physical therapy) 24
Control Group General Physical Therapy General physical therapy is administered three times a week for 8 weeks 8 weeks General physical therapy (Paretic leg supposed standing (PLSS) X 5min Reciprocal arm pulley training (RAPT) X 5min Tandem walking (TW) X 5min Sit to stand (STS) training X 5min) 24 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with hemiparesis diagnosed with stroke by physicians. Ambulant stroke patients who can perform tasks required for this study. Stroke patients who have experience sharp pain in their chest during mild to moderate activities. Stroke patients with very low blood pressure less than 90/60 mmHg or very high blood pressure greater than 170/90 mmHg. Stroke patients with advanced osteoarthritis that would not allow them to participate in the research protocols. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 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 10/01/2024 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Shika-Zaria, Kaduna State, Nigeria Shika-Zaria 810008 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lower extremity motor function, balance, ambulation and quality of life 8 weeks post intervention and 12 weeks follow-up from baseline
Secondary Outcome Lower limb strength, energy expenditure during ambulation and ambulation endurance 8 weeks post intervention and 12 weeks follow-up from baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University Teaching Hospital Shika and Tudun Wada, Zaria Zaria 810008 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Emmanuel Ikenna IGARA Kofan-Doka, Zaria Zaria 810103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Emmanuel Ikenna IGARA Kofan-Doka, Zaria Zaria 810103 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel IGARA igarae607@gmail.com +2348036045524 Kofan-Doka, Zaria
City Postal code Country Position/Affiliation
Zaria 810103 Nigeria Doctorate Degree
Role Name Email Phone Street address
Public Enquiries Ahmad RUFAI ryahmad.pth@buk.edu.ng +2348036370098 Aminu Kano Teaching Hospital, Zaria Road, Kano State
City Postal code Country Position/Affiliation
Zaria Road 700233 Nigeria Doctorate Degree
Role Name Email Phone Street address
Scientific Enquiries Emmanuel IGARA igarae607@gmail.com +2348036045524 Kofan-Doka, Zaria
City Postal code Country Position/Affiliation
Zaria 810103 Nigeria Doctorate Degree
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in stroke rehabilitation. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form Data requests can be submitted starting after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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