Pan African Clinical Trials Registry
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201904904847417 Date of Approval: 17/04/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Maze Control Training on kinaesthetic awareness in patients with chronic stroke
Official scientific title Influence of Maze Control Training on kinaesthetic awareness in patients with chronic stroke
Brief summary describing the background and objectives of the trial Background: Stroke is a leading cause of long-term disability. The main deficit caused by stroke is motor impairment, which can be described as limitation of muscle control function, movement and balance. Impaired balance after stroke is strongly associated with future function and recovery. Purpose: Was to investigate the influence of adding Maze control training to the selected conventional physical therapy rehabilitation program on kinesthetic awareness 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 01/05/2019
Actual trial start date 01/05/2019
Anticipated date of last follow up 29/06/2019
Actual Last follow-up date 29/06/2019
Anticipated target sample size (number of participants) 24
Actual target sample size (number of participants)
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maze control training three different exercise for 20 min three times per week for 2 months It was consisted of exercises to improve proprioception. This defined movement pattern encourages proprioception and motor control. Various skill levels challenge a wide variety of patients. This mode allows the patient to follow a reproducible pattern of movement throughout a maze in both static and dynamic environments. Three skill levels allow the maze to be modified to create a simple or more difficult environment for the patient to navigate through. Change the platform from static mode to dynamic mode to facilitate progression. Time counts up or down as set. Scoring is percentage-based on the net good hits/total target hits. If the cursor hits the boundary that hit is subtracted from the total possible amount of good hits. Patients were asked to repeat exercises belonging to 3 different predetermined groups of exercises. 12
Control Group traditional program for patients with thalamic syndrome four types of somatic exercises to improve preconception for one hour three times per week for 2 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 12 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) 50 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
No 01/04/2019 faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza, 11432 Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome improve proprioception deep sensation
Secondary Outcome proprioception somatosensory integration
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 Nasr city Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee Dokky Giza Egypt Individual
Secondary Sponsor Hanan Hosny M Battesha Nasr City Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee el dokky Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir N Wadee anazih@cu.edu.eg 00201222367919 Eldokky
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor in Physical Therapy for Basic science Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Principal Investigator Hanan Hosny M Battesha hanan.hosny@pt.mti.edu.eg 00201221588107 Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of physical therapy for Neuromuscular disorders and its surgery Faculty of Physical Therapy Modern University for Technology and Information
Role Name Email Phone Street address
Scientific Enquiries Amir N Wadee anazih@cu.edu.eg 00201222367919 Eldokky
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor in Physical Therapy for Basic science Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Hanan Hosny M Battesha hanan.hosny@pt.mti.edu.eg 00201221588107 Nasr city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of physical therapy for Neuromuscular disorders and its surgery Faculty of Physical Therapy Modern University for Technology and Information
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Twenty four patient's with thalamic syndrome post stroke were included in the study, age ranged from 50 to 70 years old. The duration of illness ranges from one month to six months post stroke. the body mass index ranged from 25kg/cm2 to 30kg/cm2. The patients were assessed by the proprioception test and Clinical Test of Sensory Interaction. Informed Consent Form 2 months patients referred from neurologist and diagnosed as patients with thalamic stroke from one month to 6 months confirmed by CT and/or MRI radiography, all patients able to walk alone with of without assistive device (cane).
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