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.: PACTR202010607099768 Date of Approval: 26/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Resistance exercise program in chronic stroke patients
Official scientific title Effect of resistance exercise program on coactivation of both lower extremities in chronic stroke patients
Brief summary describing the background and objectives of the trial Stroke is a frequent cause of problems in body function resulting in limitations of functional activity. Stroke generally leads to greater postural instability, and muscle weakening compared with healthy individuals. The strength of multiple muscle groups of both the paretic and non-paretic lower limbs have been shown to correlate with independence in sit to stand transfer and gait. purpose: to investigate if resistance exercises of non-paretic lower limb may improve the strength of paretic limb and the functional activities in patients with chronic stroke.
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 03/11/2019
Actual trial start date 03/11/2019
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date 31/03/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 24
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC012002079 Research Ethical Committee - Faculty of Physical Therapy- Cairo University
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
Crossover: all participants receive all interventions in different sequence 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 Resistance exercise and Standard Physical Therapy program one-hour session, 3 times per week 6 successive weeks Resistance exercises program for adductors and abductors muscles of non-paretic extremity (4 sets * 10 RM) and 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. 12
Control Group Standard Physical Therapy program one hour sessions, 3 times per week 6 successive 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. 12 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 35 to 80 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 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 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 80 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 09/09/2018 Research Ethical committee Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-Zayat St. Bein El-Sarayat, Faculty of physical Therapy Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Muscle strength using Handheld dynamometer. 2- Delayed time (Sequence of contraction) during volitional movement with the non-paretic side in adduction and abduction. after 6 weeks from the program start
Secondary Outcome Functional independence measure, FIM Physical Domains • Transfers - toilet • Transfers - bath/shower • Walk/wheelchair • Stairs • Transfers - bed/chair/wheelchair After 6 weeks of program start
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Out patients clinic 7 Ahmed El - Zayat Street, Bein El-Sarayat, Dokki, In front of Giza traffic Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof. Yasser Salem 3500 Camp Bowie Blvd Fort worth 76107 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahme d El-Zayat St. Bein El-Sarayat, Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assistant .Prof. Dr. Wael Salah Shendy Dokki Giza 12612 Egypt
Prof. Dr. Yasser Tawfeek Salem 1001 villa dr Fort Worth Texas 76120 United States of America
Prof. Dr. Hatem Samir Shehata El-manial Cairo 11562 Egypt
Mostafa Alsaid Mostafa Fahmy 4 El- Zoghoby St. Bein El-Sarayat Dokki Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wael Shendy w.shendy@pt.cu.edu.eg 00201001006711 Dokki
City Postal code Country Position/Affiliation
Dokki 12612 Egypt Assistant Professor Department of Neuromuscular disorders and its surgery Faculty of Physical Therapy Cairo Uni.
Role Name Email Phone Street address
Public Enquiries Mostafa Fahmy Alsaid_mostafa@pt.cu.edu.eg 00201286273379 Dokki
City Postal code Country Position/Affiliation
Giza 12612 Egypt Teaching Assistant Department of Neuromuscular disorders and its surgery Faculty of physical therapy Cairo Uni.
Role Name Email Phone Street address
Scientific Enquiries Yasser Salem Yasser.salem@unthsc.edu 0017189260330 1001 Villa dr , Fort worth
City Postal code Country Position/Affiliation
Texas 76120 United States of America Professor at University of North Texas Health Science Center
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries) . Also, all of the individual participant data collected during the trial, after deidentification will be shared at any time and for any purpose. Informed Consent Form Individual participant data will be available Immediately following publication, No end date All types of Individual participant data will be open and it can be accessed by any person wishes to use them such as a third party without any need for a request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/10/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/10/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information