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.: PACTR202306499250477 Date of Approval: 12/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Thermal Stimulation on Upper Extemity Function in Patients with Stroke
Official scientific title Effect of Alternating Thermal Stimulation on Sensorimotor Function and Cortical Reorganization of the More Affected Upper Extremity in Patients with Stroke: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Paresis, changes in the muscle tone, and somatosensory affection are common physical deficits of the upper extremity (UE) following stroke. Purpose. This study evaluated the effect of alternating thermal stimulation on sensorimotor function and cortical reorganization of the more affected upper extremity in stroke patients. Motor and sensory function of the (UE) was evaluated, before and after treatment using Fugl- Meyer Assessment of the Upper Extremity (FMA-UE), Box and Block Test (BBT), Perdue Pegboard Test (PPBT), and Nottingham Sensory Assessment (NSA). Cortical and sub-cortical plasticity was measured pre- and post-treatment using blood oxygenated level dependent (BOLD) functional magnetic resonance imaging (fMRI) in both groups. (Gr1) received standard physical therapy treatment program, while (Gr2) received standard treatment in addition to alternating thermal stimulation (altTS) intervention. Both groups received a total of 36 consecutive sessions for six weeks.
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 02/05/2020
Actual trial start date 02/01/2021
Anticipated date of last follow up 01/01/2022
Actual Last follow-up date 29/12/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 35
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Upper Extremity Motor Program Six sessions per week, for six consecutive weeks by a well-trained and experienced physical therapist. Session duration was 90 (min). 6 weeks Exercises for applied for the more and less affected upper extremity. Progression of exercises included increasing the number of repetitions, increasing range of motion (ROM), altering movement speed, decreasing rest time between each exercise and resistance. Some of the exercises used were based on motor learning concepts. Repetitive practice of meaningful tasks with increasing difficulty, practicing tasks that motivated patients and provide enhanced feedback, was stressed. Eccentric, isometric, or concentric muscle contractions of different movements for the more affected UE (e.g., reaching, grasp and release in addition to manipulation) (Carr, Shepherd, 2003) were practiced. 18 Active-Treatment of Control Group
Experimental Group Alternating Thermal Stimulation six sessions per week, for six consecutive weeks by a well-trained and experienced physical therapist. Session duration was 90 (min). 6 weeks (altTS) was applied on the more affected (UE) for 25 (min) in the form of two alternating cycles of heating and cooling (Chen et al., 2005) as follows: - Each patient sat comfortably on a chair with back support with both (UE) positioned on the treatment table. - Both room temperature and patients (UE) were noted before application of treatment. - Thermal agent compromised of two oversized (37cm x 60 cm) hot (~75°C) pack (Whitehall Manufacturing, CA, USA) and three cold (~ 0°C) packs (GEL1015-F, USA) wrapped with two towels, which buffered the thermal conduction were used. - To avoid any tissue damage, ceiling duration of heating and cooling stimulation to the affected UE was limited by 15 (sec) and 30 (sec) respectively. - Each patient was advised in case of developing of uncomfortable sensation to actively move the UE away from the stimuli if possible or ask for help from the treating therapist. - The session started by applying the hot pack first (hot pack wrapped in a towel) to the affected UE, for a period of 15 (sec) followed by a period of 30 (sec) without any sensory stimulation. During that period, each patient was instructed to try and move the affected (UE) actively as much as possible while focusing on the movements that required more effort. This was repeated ten times. - The same procedure was applied for the cold pack for a period of 30 (sec). 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age ranged from 40-70 years, hemiparesis caused by first ever ischemic stroke and confirmed by magnetic resonance imaging (MRI), lasting 1-6 months, medically stable according to the treating neurologist, Mini-Mental State Examination (MMSE) score greater than 24; right handed according to the Edinburgh Handedness Inventory, more affected UE scored 1, 1+, or 2 on the Modified Ashworth Scale (MAS), absence of absolute or relative contraindications to (MRI) or (fMRI) (i.e., cardiac or carotid pace maker, pregnancy, claustrophobia), and adequate understanding of instruction during the evaluation and treatment process. any cardiac arrhythmias, uncontrolled hypertension, obstructive pulmonary illness, (UE) sensory loss owing to a non-stroke pathology like peripheral neuropathy Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 02/12/2018 Faculty of Physical Therapy Research Ethical Committe
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional Magnetic Resonance Imaging fMRI task-based Pre and post Treatment
Secondary Outcome Fugl- Meyer Assessment of the Upper Extremity (FMA-UE), Box and Block Test (BBT), Perdue PegBoard Test (PPBT), and Nottingham Sensory Assessment (NSA) Pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Erada Center for Physical Therapy 408 Al Haram, Al Omraneyah Al Gharbeyah, El Omraniya, Giza Governorate Giza 3546311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Cairo, Egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hager ElSerougy 408 Al Haram, Al Omraneyah Al Gharbeyah, El Omraniya Cairo 3546311 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Walaa M. Ragab Airport Road, King Khalid International Airport Riyadh 11564 Saudi Arabia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reem M. Alwhaibi rmalwhaibi@pnu.edu.sa +966599112273 Airport Road, King Khalid International Airport
City Postal code Country Position/Affiliation
Riyadh 11671 Saudi Arabia Princess Nourah bint Abdulrahmaan University
Role Name Email Phone Street address
Public Enquiries Hoda M. Zakaria dr.hodazakaria@cu.edu.eg +201013107750 El-Tahrir st. - in front of Ben El- Sarayat Traffic
City Postal code Country Position/Affiliation
Giza 11432 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hager R. ElSerougy hager.rasmi@gmail.com +201063200039 26th of July Corridor, First 6th of October, Giza Governorate
City Postal code Country Position/Affiliation
6th of October City 3236101 Egypt Misr University for Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data published in this trial will be avaliable to researchers who provide a methodological sound proposal upon request immediatley following paper publication. Informed Consent Form 6 months Avaliable upon request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 09/06/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 09/06/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information