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.: PACTR201801002901262 Date of Approval: 21/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of motor dual task training in water on balance and gait of patients with chronic stroke: A randomized trial
Official scientific title Measurement of balance and gait of stroke patient after motor dual task training in water
Brief summary describing the background and objectives of the trial Patients with stroke are more likely to be at risk of falling, which lead to limitation in their abilities to perform daily living activities and participation in society. This falling is due to an increase in postural sway and a decline in gait ability in patients with stroke. Exercise in water helps them to safely and comfortably improve their motor ability by providing low-risk exercise environments. So the aim of this study was to determine the effect of motor dual task training in water on balance and gait of patients with chronic stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) No
Disease(s) or condition(s) being studied Nervous System Diseases,stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 30/12/2017
Actual trial start date 07/01/2018
Anticipated date of last follow up 01/07/2018
Actual Last follow-up date 02/09/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 36
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The randomization will be restricted to permuted blocks of different sizes to ensure that equal numbers will be allocated to each group. The sequences assigned to the participants will be placed in envelopes containing the allocation to each group A and B. An independent person who will be blinded to the research protocol and not otherwise involved in the trial will operat the random assignment. Sealed opaque envelopes Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The randomization will be restricted to permuted blocks of different sizes to ensure that equal numbers will be allocated to each group. The sequences assigned to the participants will be placed in envelopes containing the allocation to each group A and B. An independent person who will be blinded to the research protocol and not otherwise involved in the trial will operat the random assignment. Sealed opaque envelopes Open-label(Masking Not Used) Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group motor dual task training in hydro therapy pool 18 sessions, day after day 6 weeks patients will perform motor dual task training in hydrothrrapy pool as following: Walking while holding a ball in the non-paretic hand and stopping on a verbal order given by the physical therapy. Walking slowly forward and backward with unilateral then bilateral slow arm movements. Walking 10¿m at a comfortable speed forward, sideways, and backward while holding a 200-mL 18
Control Group motor dual task training on land 18 sessions, day after day 6 weeks the same motor dual task training will be done on land 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with age ranging from 45-55 years; (ii) duration of illness ranged from six months to one year; (iii) The muscle tone of affected lower limb ranged from 1 to 1+ according to Modified Ashworth Scale ; (iv) Patients had a brunnstrom stage of 4 for lower limb; (v) having the ability to walk 10 meters independently without assistance; Ability to understand and follow the researcher¿s instructions; (vi) Ability to communicate and understand with Mini-Mental Status Examination score of over 24 points (i) previous stroke or other neurological diseases or disorders. (ii) balance disorders due to cerebellar or vestibular dysfunction; (iii) orthopedic disorders (i.e. severe osteoarthritis, rheumatoid arthritis, peripheral nerve injuries, history of fractures or surgeries involving lower limbs, pelvis, or back, or significant low back pain); (iv) marked superficial and/or deep sensory loss, deafness, blindness and cognitive impairment (inability to follow simple verbal commands during testing); (v) an open skin wound or skin disease; (vi) fecal incontinence; (vii) fearful of walking in an underwater environment. 45 Year(s) 55 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 03/12/2017 Ethics Committee of the Faculty of Physical Therapy, Cairo University.
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El -zayat street, Dokii Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measurement of dynamic balance indices including over all stability index, anteroposterior stability index and mediolateral stability index by using the biodex balance system. Pre and post treatment
Secondary Outcome measurement of kinematic gait parameters including walking speed,stride length and step length by using the gait trainer system. Pre and post treatment.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute of Neuromotor System El-Tayar Fekry, Kornish El Nile Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy Cairo university 7 Ahmed El -zayat street, Dokii Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy Cairo university 7 Ahmed El -zayat street, Dokii Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marwa shafiek Mustafa saleh 6 October Bola El Dakror Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Saleh Marwa_shafiek2000@yahoo.com 01008342466 6 October Bola El Dakror
City Postal code Country Position/Affiliation
Giza Egypt Lecturer at basic science department, faculty of physical therapy, Cairo university
Role Name Email Phone Street address
Public Enquiries Nagwa Rehab Nagwa1102010@yahoo.com 01008124920 Bein El Sarayaat street
City Postal code Country Position/Affiliation
Giza Egypt lecturer at physical Therapy Department for Neuromuscular Disorder & its Surgery,
Role Name Email Phone Street address
Scientific Enquiries Marwa saleh marwa_shafiek2000@yahoo.com 01008342466 6 October Bola El Dakror
City Postal code Country Position/Affiliation
Giza Egypt Lecturer at basic science department, faculty of physical therapy, Cairo university.
REPORTING
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