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.: PACTR202012569619981 Date of Approval: 03/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Augmented-exercise therapy with gait and gait-related functional training in improving functional independence, quality of life and productivity in stroke survivors: A clinical control trial
Official scientific title Augmented-exercise therapy with gait and gait-related functional training in improving functional independence, quality of life and productivity in stroke survivors: A clinical control trial
Brief summary describing the background and objectives of the trial Stroke survivors present with varied degrees of gait disorders with the most prominent being the typical hemiplegic gait. Regaining walking ability in stroke survivors does not only return the stroke survivors to functioning, it plays several other roles including prevention of secondary complications common after stroke (Olawale et al, 2011). The Objective of the study is to determine the efficacy of augmented-exercise using multimodal treadmill on walking ability, functional independence, quality of life and productivity of stroke survivors and compare with that of progressive resistance exercise and conventional gait-rehabilitation approach.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 08/12/2020
Actual trial start date
Anticipated date of last follow up 08/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multimodal treadmill group 30minutes 3 times a week 24weeks Participants maximum walking speed will be measured using 10MWT(V0max). The speed is halved and used for 5minutes warm up. The belt speed will be increased slowly to participants tolerance level and is held for 10secs for the pulse to return to it's resting level. If participants maintained the speed, it will be increased by 10% of V0max during the next attempt. If participants are unable to maintain the speed, it will be reduced by 10% (V0max- 10%) (Sangeetha et al, 2019). Over course of the training the speed will be increased at least by a factor of 3 and 5 at most. Research assistants will be on guard to observe any loss of balance or any other untoward manifestation from the participants. Heart rate and percieved rate of exertion will be monitored throughout the session. 20
Control Group Progressive resistance training group 30minutes, 3 times a week 24weeks Participants will receive supervised muscle resistance training in muscles involved in walking ; hip abductors, quadriceps, plantar and dorsal flexors and the hamstring muscles. Exercise progression will be set by increasing the resistance of weights used in the exercise once the participants are able to perform more than the three sets of 10 repetition (Sabapathy et al, 2011). 20 Dose Comparison
Control Group Conventional physiotherapy group One hour, 3 times a week 24weeks Participants will continue with the conventional physiotherapy treatment in the hospital which will include functional training tailored towards their specific functional needs. 20 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Clinical diagnosed first-ever stroke survivors within the first year of stroke Stroke survivors who is at least 18years of age Stroke survivors with a score of greater than or equal to 23 on Mini- mental state examination and are able to understand verbal, graphic, pictorial and written instructions. Stroke survivors who will be able to walk 10meters independenly with or without a walking aid bit without human support. Stroke survivors with pre-existing or comorbid neurological or psychiatric conditions such as dementia, schizophrenia, seizure or epilepsy. Stroke survivors with significant visual impairment which is not amendable to corrective visual aids. Stroke survivors with concomitant health conditions like anthropathy, osteopathy, myopathy, severe diseases of the lung, heart liver or kidney. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 23/11/2020 Health Research ethics committee
Ethics Committee Address
Street address City Postal code Country
College of Medicine, University of Lagos, Idi Araba Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 10-Meter walk test: Assesses walking speed in meters per second over a short duration. It Assesses functional mobility and gait. Participants is instructed to walk a set distance of 10meters . Time is measured while the individual walks the set distance. It wil be used to measure gait parameters such as syep length, stride length, speed, maximum speed and cadence Pre, mid and post intervention
Secondary Outcome Borg Scale: Borg rating of percieved exertion is a way of measuring physical intensity level. it is used for rating exertion and breathlessness during physical activity.The scale starts with no feeling of exertion which rates 6 and ends with very , very hard which rates a 20 Time of intervention especially for the multimodal treadmill group
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy department University of Port Harcourt Teaching Hospital East/West Road Alakahia, River State Port Harcourt 500211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nwaedozie Obianuju 18 Sam Wobo Street off Ada George Road Port Harcourt 500211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NWAEDOZIE OBIANUJU 18 Sam Wobo Street Port Harcourt 500211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NWAEDOZIE Obianuju uju4christ2000@yahoo.com +2348069511770 18 Sam Wobo Street
City Postal code Country Position/Affiliation
Port Harcourt 500211 Nigeria Physiotherapis
Role Name Email Phone Street address
Scientific Enquiries Gbiri Caleb calebgbiri@yahoo.com 08033598072 University of Lagos
City Postal code Country Position/Affiliation
Lagos 12003 Nigeria Senior physiotherapy lecturer
Role Name Email Phone Street address
Public Enquiries Aiyegbusi Ayoola bogphysio@yahoo.com 08023212514 University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Senior physiotherapy lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participants data collected during the trial after deidentification (text, tables, RCT figures and appendices will be shared Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year Data will be shared with anyone who wishes to access it. Data will be analysed to achieve aims in the approved proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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