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.: PACTR201506001051336 Date of Approval: 02/03/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Raised-Heel Stair Descent Exercises on Lower Limb Postural Control and Functional Ambulation in the Sub-Acute Phase of Post Stroke Recov
Official scientific title THE EFFECT OF RAISED-HEEL STAIR DESCENT EXERCISES ON LOWER LIMB POSTURAL CONTROL AND FUNCTIONAL AMBULATION IN THE SUB-ACUTE PHASE OF POST STROKE RECOVERY
Brief summary describing the background and objectives of the trial The ability to functionally ambulate after sustaining a stroke influences a patient¿s ability to reintegrate into society. In order to be considered a functional ambulator one needs the ability to walk at a speed of 0.07 meters per second, negotiate uneven surfaces and ascend and descend stairs. Stair descent is one of the most difficult activities to retrain after a stroke has occurred. If stair descent can be retrained with the correct sequence of movement it may improve a person living with a stroke¿s ability to ambulate functionally and may improve the person¿s quality of life. The primary aims of the study are to determine: ¿The effect of raised-heel stair descent exercises on lower limb postural control. ¿The effect of raised-heel stair descent exercises on a patient¿s ability to ambulate functionally. ¿The influence of raised-heel stair descent exercises on the walking speed and gait effort of patients in the sub-acute phase of recovery after a stroke ¿The long-term effect of raised-heel stair descent exercises on the quality of life of a person living with a stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 16/02/2015
Actual trial start date 09/03/2015
Anticipated date of last follow up 07/09/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
269/2014 University of Pretoria Ethics Committee
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 Permuted block randomisation, 8 participants per block, not variable Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard rehabilitation by therapists Five days per week, daily 45 minutes per session Standard physiotherapy exercises to improve balance, gait and muscle strength 16 Historical
Experimental Group Standard rehabilitation with additional raised-heel stair descent exersices Five days per week, 20 steps per day 45 minutes treatment per session, for two weeks Standard physiotherapy exercises to improve balance, gait and muscle strength with additional raised-heel stair descent exercises on the intervention step 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Age: 30 to 65 years old. ¿Gender: Male and female of all racial groups. ¿Participants who have sustained an ischemic stroke, to ensure homogeneity of the sample. ¿Participants should be able to walk ten meters, with or without an assistive device. ¿Participants should be in the sub-acute of recovery after sustaining a stroke, i.e. two weeks to six weeks post-stroke. ¿Participants who have sustained multiple previous CVIs ¿ as this will influence the participant¿s ability to show recovery and relearn motor tasks. ¿Participants who suffer from severe co-morbidities such as uncontrolled hypertension or diabetes, to ensure the safety of participants in the trial. ¿Participants with severe hemineglect ¿ this will influence the participants ability to climb stairs safely (as observed by the treating physiotherapist) ¿Participants who are legally blind, as they will not be able to utilize the visual cues and the activity may become unsafe to perform. ¿Participants with a shoe size smaller than the number five ¿ as they will not be able to safely tolerate the heel-raise. 30 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 31/07/2015 University of Pretoria, Faculty of Health Sciences Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ouma's Hoop Road Pretoria 0007 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional Gait assessment Baseline At completion (two weeks)
Primary Outcome Telephonic Lower Extremity Functionality Scale Baseline Completion (two weeks) Three month follow up Six month follow up
Secondary Outcome QUALYSIS 3D gait analysis Baseline Completion (two weeks)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Life Riverfield Lodge Rehabilitation Centre 34 Southernwoods Road Randburg 1747 South Africa
Summit Rehabilitation Schoeman Street, City Central Pretoria 0001 South Africa
Tshwane Rehabilitation Centre Dr Savage Road, Gezina Pretoria 0007 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Meiring Naude Road, Brummeria Pretoria 0001 South Africa
National Research Foundation Meiring Naude Road, Brummeria Pretoria South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Foundation Meiring Naude Road, Brummeria Pretoria 0001 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Carina Eksteen 1 Bopelo Road, Gezina Pretoria 0007 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maria Elizabeth Cochrane cochrane.m2@gmail.com 0798950641 55 Montery Place, Griffith Street, Equestria
City Postal code Country Position/Affiliation
Pretoria 0184 South Africa Principle investigator
Role Name Email Phone Street address
Public Enquiries Diphale Joyce Mothabeng joyce.mothabeng@up.ac.za 012 345 2023 1 Bopelo Road, Gezina
City Postal code Country Position/Affiliation
Pretoria 0007 South Africa Co-supervisor
Role Name Email Phone Street address
Scientific Enquiries Carina Eksteen cochrane.m2@gmail.com 0798950641 1 Bopelo Road, Gezina
City Postal code Country Position/Affiliation
Pretoria 0007 South Africa Supervisor
REPORTING
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