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.: PACTR201908825773318 Date of Approval: 26/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Influence of Sensory Integration Training on posture stability in patient with thalamic syndrome
Official scientific title Influence of Sensory Integration Training on posture stability in patient with thalamic syndrome
Brief summary describing the background and objectives of the trial PURPOSE: to detect the effect of sensory integration training on posture stability in patient with thalamic syndrome. BACKGROUND: Treatment of thalamic syndrome after a thalamic stroke is generally based on pharmacological approach as it is low responsive to physiotherapy. In this study, the use of sensory integration training for improving posture stability in a subject after a stroke involving thalamus is presented. Within the scope of this study, the following conclusion may be warranted, physical therapists should use sensory integration training to improve postural instability and posture sway in patients with thalamic syndrome.
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 15/04/2019
Actual trial start date 15/04/2019
Anticipated date of last follow up 12/06/2019
Actual Last follow-up date 12/06/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Recruiting
Publication URL https://www.magonlinelibrary.com/journal/ijtr
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sensory integration training 3 types of posture stability exercises applied in 15 min three times per week for two months Sensory Integration Training: this programme was designed according to American Society of Neuro-rehabilitation. Balance training consisted of exercises to improve both feedback and feed forward postural reactions. Patients were asked to repeat exercises belonging to 3 different predetermined groups of exercises. The patients performed exercises of self-destabilization of the center-of-body mass consisted of voluntary motor actions in static or dynamic conditions (e.g., transferring their body weight onto the tips of the toes and onto the heels as in get to stand from sitting on stool; alternating stand on the right leg then the leg; stand with step forward or lateral direction. These tasks mainly involved feed forward postural control. In addition to tasks that externally induced destabilization of the centre-of-body mass. The patient was required to maintain balance while standing on foam support bases of different consistency, on moveable balance board, or while the therapist was disturbing the patient’s stability by sternal or dorsal pulling in order to induce perturbations in the anterior and posterior direction. These tasks mainly involved feedback postural control. Also exercises emphasized coordination between leg and arm movements during walking as well as locomotor dexterity over an obstacle course and other potentially destabilizing activities. 15
Control Group traditional program for patient with thalamic syndrome four types of somatic exercises will apply for one hour three times per week for two months Tactile discrimination. We used 3 tactile discrimination tasks: sandpaper surfaces of different grains, surfaces made of different materials (eg, rubber, cloth, paper), and grating ori- entation. All exercises were performed without visual control. In the case of the sandpaper exercises, the operator passively guided tactile exploration to avoid possible skin lesions. Object recognition. This group included 3 tasks of tactile object recognition. In it, the blindfolded patient was requested to perform these tasks: manipulate a target object and discriminate it visually among 3 objects; manipulate a group of small objects (eg, rice, bolts, stones) and then discriminate visually among the 3 groups of objects; and manipulate 2 objects simultaneously with the affected and unaffected hand and then report whether the 2 objects were the same or different. Joint position sense. For these training activities, we used the same box as in the testing procedure for the joint position sense testing. This group included 3 tasks of proprioceptive discrimination. The operator moved the patient’s wrist or metacarpophalangeal joints at different angular positions by using the same methods previously described for the joint position test. The patient was required to choose which of 3 suggested positions of the protractor scale above the box corresponded to the real hand position. Using the affected hand, the patient was requested to actively reproduce the position indicated by the operator on the angular scale. The patient was asked to reproduce a gesture shown by the operator with the affected hand (ie, gesture of OK) while keeping her/his arm inside the box. Weight discrimination. The blindfolded patient was required to weigh an object with the affected hand. Then, he/she was required to weigh 3 objects with the unaffected hand and choose which of them corresponded in weight to the previous object. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The main inclusion criteria included: (1) diagnosis of first-ever stroke <1 month, All patients underwent brain computed tomography (CT) scan on admission and 2 weeks after stroke. (2) no cardiac or orthopedic problem before stroke, (3) no cognition problem and able to follow directions indicated by therapist during experiment, (4) motor deficit of the upper limb under Brunnstrom stage IV (5) The selection of patients should include control of their blood glucose level i.e. HA1c≤ 6 and (6) body mass index ranged between 25 to 30 kg/cm2. Exclusion criteria were: (1) diabetic history or sensory impairment attributable to peripheral vascular disease or neuropathy, (2) Visual disturbance, (3) uncontrolled hypertension), (4) Balance disturbance rather than thalamic syndrome (e.g. ear problems, Labyrinthitis, diabetic neuropathy), (5) History of pedal ulcer in the lower limb or amputation, (6) Advanced arthritis, osteoporosis in the lower limbs and recent or old mal union fractures of lower limbs, (7) Obesity (BMI more than 30 kg/m2) and (8) Acute nerve root compression (radicuolopathy) affecting lower limbs. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 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 31/03/2019 Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed elzyat st -Tahrir st. - in front of Ben El- Sarayat Traffic - 11432 Giza,Dokki, Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improve posture instability and posture sway posture sway, overall stability index, ant./post. index and med./lat. index
Secondary Outcome improve overall posture stability and limits of stability in patient with thalamic syndrome posture sway, overall stability index, ant./post. index and med./lat. index
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Modern University for Technology and Information El-hadaba El-Wosta, Mokatam, 5th district, Cairo, Egypt. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hanan Hosny M Battesha el dokki Cairo 201211 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee el dokky Giza Cairo Egypt Individual
Secondary Sponsor Hanan Hosny M Battesha Nasr city Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir Nazeh Wadee assistant professor of physical therapy cairo university El tahrir st. ben el-saryat, dokky Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir Wadee anazih@cu.edu.eg 00201222367919 el dokky
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor in Physical Therapy of Basic science department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Principal Investigator Hanan Battesha Hanan.hosny@pt.mti.edu.eg 00201221588107 nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer in physical therapy Physical Therapy of Neuromuscular disorders and its surgery department Faculty of Physical Therapy Modern University for Technology and Information
Role Name Email Phone Street address
Public Enquiries Hanan Battesha Hanan.hosny@pt.mti.edu.eg 00201221588107 nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer in physical therapy Physical Therapy of Neuromuscular disorders and its surgery department Faculty of Physical Therapy Modern University for Technology and Information
Role Name Email Phone Street address
Scientific Enquiries Amir Wadee anazih@cu.edu.eg 00201222367919 el dokky
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor in Physical Therapy of Basic science department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data under lie the results reported in this article (text, tables, figures), by international publication Study Protocol beginning from 6 to 12 months after publication controlled access through authors mails
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