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.: PACTR201801002927119 Date of Approval: 01/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of pelvic control exercises on gait in stroke patients
Official scientific title Effect of pelvic control exercises on pelvic asymmetry and spatiotemporal gait parameter in stroke patients
Brief summary describing the background and objectives of the trial Stroke is one of the principal causes of morbidity and mortality in the developed world. It is the leading cause of disability in all industrialized countries. Survivors can suffer several neurological deficits or impairments as hemiparesis, communication disorders, cognitive deficits or disorders in visuo-spatial perception (Schmidt et al., 2007).Hemiplegia is one of the most common impairments after stroke. It contributes significantly to reduce gait performance (Flansbjer et al., 2005). Gait in patients after stroke is characterized by reduced preferred walking speed, cadence, stride length and symmetry, prolonged stance duration on the non-paretic side and reduced step length on the paretic side (Plummer et al., 2007).The forward and backward pelvic tilts are frequently affected in stroke patients.They have a more forward-leaning posture with an anteriorly tilted pelvis in standing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PALM
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 10/10/2017
Actual trial start date
Anticipated date of last follow up 25/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised the patients were assigned randomly by random generator and by using permuted block the allocation will be determined by a third person( the holder of the situated off site) Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group same selected physical therapy program in addition to pelvic control exercises. 3 times/ week 6 week Pelvic control exercises:a-Pelvic tilting exercises includ¿ Anterior and posterior pelvic tilting from sitting ¿Lateral pelvic tilting from sitting position. ¿Sit to standing exercises bb- Pelvic stabilization exercises include: ¿ Weight shifting on both lower limbs from standing ¿Bridging exercises- 15
Control Group Selected physical therapy program 3 times/ week 6 week Prolonged stretching exercises for shortened muscles,Facilitation of the weak muscles, Strengthening exercises for the weak muscles which have grade three or above in power, Proprioceptive neuromuscular facilitation and Gait training. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a)Inclusion criteria: 1.Patient's age ranges from 45 to 60 years. 2.Spasticity of lower limbs ranges from (grade 1: 1+) according to modified Aschworth scale. 3. Ability of the patient to walk with or without assistive devices. 4.Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24). 5.Patients with body mass index not more than 30. (b)Exclusion Criteria: The patients will be excluded if they have: 1.Neurological diseases that affect gait other than stroke (eg: Multiple sclerosis, Peripheral neuropathy, Parkinsonism¿.etc.). 2.Haemorrhagic stroke patients. 3.Musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy. 4.Cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders. 5.Visual, auditory problems. 45 Year(s) 60 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
No 15/01/2018 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El zyad street, dooki, giza, egypt GIZA Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome gait before and after completion of study
Primary Outcome pelvic asemmetry before and after completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Clinic of faculty of physical tharapy, Cairo University 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical tharapy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt University
Primary Sponsor cairo university giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. moshera hassan darwish 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
DR. mohammed soliman el tamawy 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
dr. heba ahmed metwally 7 Ahmed El Zayad street, Dooki, Giza, Egypt giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator moshera darwish dr.moshera11@yahoo.com 01015163617 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt
Role Name Email Phone Street address
Public Enquiries heba ahmed dr_hobi@yahoo.com 01289213128 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt doctor
Role Name Email Phone Street address
Scientific Enquiries mohammed el tamawy eltamawy@hotmail.com 1001435058 7 Ahmed El zayad street
City Postal code Country Position/Affiliation
giza Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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