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.: PACTR201810717634701 Date of Approval: 01/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Task-Specific Training With Multi-Sensory Biofeedback on Ambulation, Balance, Cognition and Societal Participation in Individuals Post Stroke
Official scientific title Task-Specific Training With Multi-Sensory Biofeedback on Ambulation, Balance, Cognition and Societal Participation in Individuals Post Stroke
Brief summary describing the background and objectives of the trial Lower-limb motor and functional recovery is an integral aspect of stroke survivors’ normal functioning. More attention has been tailored at investigating the effectiveness of lower limb task-oriented exercises on ambulatory performance in stroke survivors. Although previous studies have focused on improving walking efficiency and independence ambulatory performance in post-stroke individuals, their approaches involved many training strategies made up of varied components which are cumbersome and often time not practicable in the clinical setting as they are not users friendly especially the patients. Therefore there is need for more effective approach in achieving these goals. The involvement of a multi-sensory biofeedback that will entail the combination of audio, visual and kinesthetic feedback with task training as against previous monolithic form of feedback may provide better approach in achieving effective gait and balance rehabilitation in stroke survivors. Hence, the aim of this study is to investigate the efficacy of varied components of task-specific training alone and with multi-sensory biofeedback on ambulation, balance, cognition and societal participation in post-stroke individuals.
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 30/09/2018
Actual trial start date
Anticipated date of last follow up 30/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Mobility related overground task specific training. This intervention group is called Group A. I hour of intervention two times in a week Twelve (12) weeks Over-ground task-specific training activity which involves mobility-related task-specific exercises such as sit to stand exercises, patterned distance walking both at short and long distance intervals; walking and carrying/picking object while walking and stair climbing exercises.The tasks/activities will be progressed from week 1 to week 12 by starting with simpler and less complex tasks and increasing the complexity and difficulty of the tasks as intervention progress. 24 Active-Treatment of Control Group
Experimental Group Mobility related overground task specific training with multisensory biofeedback. Called Group C 1 hour of intervention two times in a week Twelve (12) weeks Over-ground task specific training activity which involves mobility-related task-specific exercises such as sit to stand exercises, patterned distance walking both at short and long distance intervals; walking and carrying/picking object while walking and stair climbing exercises combined with multi-sensory biofeedback (Audio, Visual and Kinesthetic feedback).The tasks/activities will be progressed from week 1 to week 12 by starting with simpler and less complex tasks and increasing the complexity and difficulty of the tasks as intervention progress. 24
Control Group Balance related overground task specific training. This intervention group is called Group B. 1 hour of intervention two times in a week Twelve (12) weeks Over ground task-specific training activity that involve balance-related task-specific exercise such as stepping related task-oriented exercises, stepping over obstacles, obstacle avoidance exercises and tandem walking.The tasks/activities will be progressed from week 1 to week 12 by starting with simpler and less complex tasks and increasing the complexity and difficulty of the tasks as intervention progress. 24 Active-Treatment of Control Group
Experimental Group Balance related overground task specific training with multisensory biofeedback . Called Group D. 1 hour of intervention two times in a week Twelve (12) weeks Over ground task specific training activity that involve balance-related task-specific exercise such as stepping related task-oriented exercises, stepping over obstacles, obstacle avoidance exercises and tandem walking combined with multi-sensory biofeedback (Audio, Visual and Kinesthetic feedback).The tasks/activities will be progressed from week 1 to week 12 by starting with simpler and less complex tasks and increasing the complexity and difficulty of the tasks as intervention progress. 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Post-stroke individuals who are ambulant and can comprehend information in English and/or Hausa Languages. ii. Post-stroke individuals of not less than 18 years of age. iii. Post-stroke individuals with first-ever diagnosed stroke of at most 6 months duration. iv. Post-stroke individuals who have ability to walk independently unaided at least for 10 meters and at self faced speed v. Post-stroke individuals who possess ability to maintain balance of > 30 seconds unsupported without falling vi. Post-stroke individuals who scores >3 on functional ambulation classification/categories (FAC) . vii. Post-stroke individuals with Modified ashworth scale score of less than 3 . i. Post-stroke individuals with severe cognitive impairment (To be determine using minimental state examination) as well as those with perceptual impairment, Psychiatric disorders and seizure disorders. ii. Post-stroke individuals with severe cardiopulmonary compromised, severe visual and auditory defects that can interfere with their walking ability. iii. Post-stroke individuals with history of pre-existing neurological conditions that would influence gait (e.g. Parkinson’s disease, Cerebella Ataxia). iv. Post-stroke individuals who are bed ridden and those with unstable cardiovascular disease/status. v. Post-stroke individuals with musculoskeletal problems such as amputation, previous lower limb Orthopaedic surgeries, prosthetics devices, any form of severe incapacitating arthritis, myopathies and other athropathies that can interfere with walking. vi. Post-stroke individuals with other severe medical conditions such as severe diseases of the heart, liver, kidney and lungs 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 11/04/2018 Aminu Kano Teaching Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zaria Road Kano 3452 Nigeria
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 10/04/2018 Health Research Ethics Committee of Kano State Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Post office Road Kano 3066 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gait spatiotemporal variables which will be assessed using 10 meter walk test At Baseline, after 6 weeks of intervention, after 12 weeks of intervention and during 3 months follow-up period post intervention
Primary Outcome Walking enduarance will be assessed using Six minute walk test-6MWT At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Ambulatory self confidence which will be assessed using Ambulatory self confidence questionnaire At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Lower extremity function which will be assessed using lower extremity functional scale. At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Lower extremity motor function which will be assessed using Fugl-Meyer assessment of motor recovery after stroke. At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Functional ambulatory profile/time which will be assessed using Modified Emory Functional Ambulatory Profile At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Mobility which will be assessed using Modified Rivermead Mobility Index. At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Balance which will be assessed using Berg Balance Scale At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 months follow-up period post intervention.
Primary Outcome Cognition which will be assessed using modified minimental state examination. At baseline, after 6 weeks of intervention, after 12 weeks of intervention, during 3 month follow-up period post intervention.
Secondary Outcome Ambulatory level which will be assessed using functional ambulatory classification At baseline
Secondary Outcome Spasticity status which will be assessed using modified Asthworth scale At baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria Road Kano 3452 Nigeria
Murtala Muhammad Specialist Hospital Kofar Mata Road Kano 3540 Nigeria
Muhammad Abdullahi Wase Specialist Hospital Hospital Road Kano 3540 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano and Tertiary Education Trust Fund Gwarzo Road Kano 3011 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano Gwarzo Road Kano 3011 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jibrin Sammani Usman jibrilphysio@yahoo.com +2348099995088 Gwarzo Road
City Postal code Country Position/Affiliation
Kano 3011 Nigeria Lecturer at the Department of Physiotherapy Faculty of Allied Health Sciences College of Health Sciences Bayero University Kano Nigeria
Role Name Email Phone Street address
Public Enquiries Jibrin Sammani Usman jibrilphysio@yahoo.com +2348099995088 Gwarzo Road
City Postal code Country Position/Affiliation
Kano 3011 Nigeria Lecturer at the Department of Physiotherapy Faculty of Allied Health Sciences College of Heath Sciences Bayero University Kano Nigeria
Role Name Email Phone Street address
Scientific Enquiries Jibrin Sammani Usman jibrilphysio@yahoo.com +2348099995088 Gwarzo Road
City Postal code Country Position/Affiliation
Kano 3011 Nigeria Lecturer at the Department of Physiotherapy Faculty of Allied Health Sciences College of Health Sciences Bayero University Kano Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information