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.: PACTR202209909344807 Date of Approval: 19/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE EFFECT OF LOWER LIMB SENSORY TRAINING ON POSTURAL STABILITY IN STROKE PATIENTS
Official scientific title THE EFFECT OF LOWER LIMB SENSORY TRAINING ON POSTURAL STABILITY IN STROKE PATIENTS
Brief summary describing the background and objectives of the trial Worldwide, cerebrovascular accidents (stroke) are the second leading cause of death and the third leading cause of disability according to the world health organization (WHO). The disability caused by stroke isn’t limited to motor weakness only. Impairments in sensorimotor function are also present and can cause functional limitations. this study was done to determine the efficacy of lower limb sensory training on postural stability in stroke patients. this goal was achieved by recruiting thirty male ambulant patients with ischemic stroke in the distribution of anterior circulation with a modified Ashworth scale not exceeding 1+. The ages of the participants ranged from 50-65 years, duration of the illness was three to six months from the onset. They were randomly assigned into two equal groups, study group (A) and control group (B). The patients in study group (A) were treated with a conventional program of therapeutic exercises for stroke in addition to a designed physical therapy program consisting of sensory-based interventions targeting the affected lower limb. Control group (B) patients were treated with the conventional program of therapeutic exercises for stroke. The treatment was conducted three sessions per week for six weeks. Assessment of postural stability was done before and after interventions by using the berg balance scale (BBS) and the Biodex balance system indices; the mediolateral stability index (MLSI), the anteroposterior stability index (APSI) and, the overall stability index (OASI) In eyes open and eyes closed conditions.
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 05/12/2020
Actual trial start date 25/12/2020
Anticipated date of last follow up 14/12/2021
Actual Last follow-up date 24/01/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional physical therapy program for stroke patients three days a week six weeks 1. Stretching exercises: a prolonged stretch was done for the calf muscle (gastrocnemius and soleus) so maintain and improve its flexibility which when affected can limit voluntary movement done by the dorsiflexors, the stretch was performed at the start of each session for a period of 30 secs and repeated three to four times. 2. Facilitation for weak muscles: by using the principles of the length tension relationship and other facilitatory techniques such as light resistance, isometric and eccentric contractions and tapping. 3. Strengthening exercises: to improve the strength of the muscles exceeding grade 3 in the affected lower limb such as: a) Straight leg raising exercise: to improve hip flexors and knee extensors strength which are commonly affected after stroke, patients were instructed to flex the affected lower limb while maintaining their knees in extension, hip in neutral position and their ankle in dorsiflexion. The exercise was done for 3 sets, each set ranged from 10 to 15 repetitions. b) Clamshell exercise: for improving hip abductors and external rotators strength. Patients were instructed to lie on their unaffected side with their knees and their hips flexed at 45-degree angle, patients were asked to open between their knees while maintaining both their ankles on top of each other and their pelvis stable, the exercise was repeated for 3 sets, each set included 10 to 15 repetitions. c) Bridging exercises: to improve the strength of hip extensors, abductors and ankle stabilizers. Patients were instructed to lay in a hock lying position and elevate their pelvis while bearing their weight on their feet and upper trunk, the exercises was done for 3 sets, each set included 10 to 15 repetitions, at first it was done bilaterally and then progressed to unilaterally on the affected limb. 15 Active-Treatment of Control Group
Experimental Group Active sensory training three days per week six weeks . the active sensory training method that was used was a proprioceptive training program. The program consisted of three phases of training done in a step standing and standing position; the first phase was done using a soft stable surface (a block), and in the second and the third phases of training was done by using an unstable surface (a two-dimensional balance board). Each phase had a series of tasks done in both eyes opened and closed conditions. Five trials were done for each task, and they were considered a set, between each trial the patient was allowed to take a break for 10 seconds, the patient was asked to perform five sets of each task to be considered completed and move on to the next. Phase 1 Task 1: Patient assumed step standing position with his affected limb on the block and the unaffected limb on the ground. The patient was asked to maintain the position for 20 secs. Task 2: Patient assumed step standing position with his affected limb on the block and the unaffected limb on the ground and was asked to perform upper limb movement or reach in all directions for the purpose of weight shifting while maintaining stability Task 3: Patient assumed step standing position with his unaffected limb on the block and his affected limb on the ground and asked to maintain this position for 20 secs. Task 4: Patient assumed step standing position with his unaffected limb on the block and his affected limb on the ground and was asked to perform upper limb movement or reach in different directions for the purpose of weight shifting while maintaining stability. Phase 2 Task 1: patient assumed step standing position with his affected limb on the balance board and the unaffected limb on the ground. The patient was asked to maintain the position for 20 secs. Task 2: patient assumed step standing position with his affected limb on the balance board and the unaffected limb on the ground, reaching exercises and upper limb movements were done to encourage patients to shift their weight in all directions Task 3: patient assumed step standing position with his unaffected limb on the balance board and his affected limb on the ground and asked to maintain this position for 20 secs. Task 4: patient assumed step standing position with his unaffected limb on the block and his affected limb on the ground. reaching exercises were done and upper limb movements to encourage patients to shift their weight in all directions Phase 3 Task 1: Patients were asked to assume standing positing on the 2-dimensional balance board and remain stable for 20 secs Task 2: Patients were asked to assume standing position on the 2-dimensional balance board while been asked to reach in multiple directions or perform upper limb movements for the purpose of achieving weight shifting. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patient's age ranged from 50-65 years. 2. All participants had an ischemic stroke in the anterior circulation with a duration of illness ranged from three to six months prior to enrollment. 3. Mild spasticity of the affected lower limb ranging from 1 to 1+ according to modified Ashworth scale. 4. All patients were ambulant. 5. Patients had sufficient cognitive and communication abilities and were able to understand and follow instructions (Mini-Mental Scale >24). 6. Patients had a body mass index that did not exceed 35. 7. Patients were medically stable. 1) Musculoskeletal disorders that can have a negative effect on the patient’s gait such as severe arthritis or contractures that led to a fixed deformity. 2) Cognitive impairment (a score less than 24 according to the MMSE). 3) Patients with congestive heart failure, unstable angina, or shortness of breath. 4) Patients with visual or auditory defects. 5) Patients with any history of vestibular system defects. 6) Patients with diabetic neuropathy or peripheral neuropathy. Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 65 Year(s) Male
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 11/10/2020 Research Ethical committee of the faculty of physical therapy at Cairo university
Ethics Committee Address
Street address City Postal code Country
7 El Zayaat Street Dokki 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Biodex balance system indices in open eyes condition Pre and Post treatment
Secondary Outcome The Berg balance scale score Pre and Post treatment
Primary Outcome Biodex balance system indices in eyes closed condition Pre and Post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy. Cairo university 7 El Zayaat street Dokki 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Heba El Saeid 11 Ahmed Ibrahim street Giza 12551 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy at Cairo university 7 El Zayaat Dokki 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abd El Aleem Abd El Fatah Attia 7 El Zayaat Dokki 12511 Egypt
Sandra Mohamed Ahmed 7 El Sarayaa street Cairo 35855 Egypt
Abdelaziz Abdelaziz Mohammed Elsherif 7 El Zayaat Dokki 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba El Saeid heba.el.saeid@hotmail.com +201005628254 11 Ahmed Ibrahim street
City Postal code Country Position/Affiliation
Giza 12616 Egypt Main investigator
Role Name Email Phone Street address
Scientific Enquiries Abdelaziz Elsherif dr_ebncena2015@hotmail.com +201007228215 7 El Zayaat street
City Postal code Country Position/Affiliation
Dokki 12511 Egypt supervisor
Role Name Email Phone Street address
Public Enquiries Sandra Ahmed sandra.ahmed@kasralainy.edu.eg +201005162225 7 El Sarayaa street
City Postal code Country Position/Affiliation
Cairo 802125 Egypt supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes results would be published Informed Consent Form,Statistical Analysis Plan 10 Months Open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/09/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 13/09/2022 Result - 16/09/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information