Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000856617
Ethics application status
Approved
Date submitted
31/07/2014
Date registered
8/08/2014
Date last updated
8/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between lower limb coordination and walking speed following stroke; an observational study
Scientific title
The relationship of walking speed and lower limbs coordination between healthy participants and chronic stroke participants.
Secondary ID [1] 285089 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 292628 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292988 292988 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An observational study – approximately 2 hours in total of 1-2 measurement sessions to measure and compare the relationship between walking speed and lower limb coordination in stroke survivors and healthy people of similar age
Intervention code [1] 289934 0
Not applicable
Comparator / control treatment
Healthy participants between 18-85 years of age without any history of stroke and able to walk >1.2m/s unaided over 10 metres
Control group
Active

Outcomes
Primary outcome [1] 292808 0
Walking speed (m/s) will be measured using the 10 metre walk test
Timepoint [1] 292808 0
One off measurement
Primary outcome [2] 292849 0
Coordination of lower limb muscles (Laboratory): Jerk and Amplitude of hip flexion/extension, knee flexion/extension and ankle dorsiflexion/plantarflexion using an accelerometer which records the raw acceleration of the movement at a sampling rate of 30Hz
Timepoint [2] 292849 0
One off measurement
Primary outcome [3] 292850 0
Coordination of lower limb muscles (Clinical) using the Lower Extremity Motor Coordination Test (LEMOCOT)
Timepoint [3] 292850 0
One off measurement
Secondary outcome [1] 309707 0
Walking capacity (distance walked in metres) will be measured using the six minute walk test
Timepoint [1] 309707 0
One off measurement
Secondary outcome [2] 309799 0
Contracture of the plantarflexor muscles will be measured by measuring the maximal passive range of ankle dorsiflexion using a standardised protocol and subtracting the difference between the intact and affected leg (Stroke group only)
Timepoint [2] 309799 0
One off measurement
Secondary outcome [3] 309800 0
Proprioception of lowe limb muscles will be measured using a matching task with use of Perspex sheet (Stroke group only)
Timepoint [3] 309800 0
One off measurement
Secondary outcome [4] 309801 0
Spasticity in the ankle plantarflexion muscles will be measured using the Modified Tardieu Scale (Stroke group only)
Timepoint [4] 309801 0
One off measurement

Eligibility
Key inclusion criteria
Stroke participant groups: Stroke (> 6 months).
Walking speed greater than or equal to 0.6m/s (selected to ensure a spread of walking speeds within the range of 0.6m/s to 1.2m/s, five participants will be distributed onto 5 different baskets of walking speed range equally divided from 0.6m/s to 1.2m/s, e.g. 5 participants will be in 0.6-0.72 m/s basket according to the result of the 10 metre walk test).
Able to walk unaided over 10 metres.
Manual muscle test equal or greater than 4/5 of the hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion and ankle dorsiflexion and able to follow verbal instructions

Healthy participant groups: no history of stroke, walking speed equal or greater than 1.2m/s unaided over 10 metres.
Manual muscle test is 5/5 of the hip flexion, hip extension, knee flexion, knee extension, ankle plantarflexion and ankle dorsiflexion and able to follow verbal instructions
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to walk unaided for 10 metre

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/08/2014
Actual
25/08/2014
Date of last participant enrolment
Anticipated
31/12/2015
Actual
9/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2799 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 8492 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 289694 0
Self funded/Unfunded
Name [1] 289694 0
Country [1] 289694 0
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 288389 0
None
Name [1] 288389 0
Address [1] 288389 0
Country [1] 288389 0
Other collaborator category [1] 278074 0
Hospital
Name [1] 278074 0
Royal Prince Alfred Hospital
Address [1] 278074 0
Physiotherapy Department, Level 5, 57-59 Missenden Road, Camperdown 2050 NSW
Country [1] 278074 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291437 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 291437 0
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042

Ethics committee country [1] 291437 0
Australia
Date submitted for ethics approval [1] 291437 0
Approval date [1] 291437 0
22/01/2014
Ethics approval number [1] 291437 0
X13-0384 & HREC/13/RPAH/536

Summary
Brief summary
The aim of this study is to measure the impact of the coordination of leg muscles on walking parameters in people following stroke. A quantitative observational study will be carried out. Thirty stroke survivors will be recruited from past or present patients referred for physiotherapy after stroke at Royal Prince Alfred Hospital. Thirty healthy control participants will also be recruited from spouses of the stroke survivors or from the community. Inclusion criteria for the Stroke participants includes a history of stroke for 6 months or more; aged between 18-85 year olds; able to walk independently prior to the stroke; muscle strength equal or stronger than 4/5 on manual muscle test for the hip flexors and extensors, knee flexors and extensors, and the ankle plantarflexors and dorsiflexors; and able to walk unaided over 10 metres at a speed equal or greater than 0.6m/s (which is the minimal speed for community ambulation). The inclusion criteria for the Healthy control participants includes no history of stroke; age between 18-85 year olds;, able to walk unaided over 10 meters at a speed greater than 1.2m/s; and no weakness in the hip, knee and ankle muscles.
Each participant will attend a 2 hour measurement session over 1-2 visits at Royal Prince Alfred Hospital. The measurement session will involve clinical tests of walking speed and capacity (10 metre walk test and six minute walk test respectively); ; a clinical test of lower limb coordination (Lower Extremity Motor Coordination Test - LEMOCOT) and a laboratory measure of lower limb coordination (raw acceleration of hip flexion/extension, knee flexion/extension and ankle plantarflexion/dorsiflexion using an Actigraph GT3X accelerometer). In addition, standard clinical measures will be used to measure the impairments of contracture, spasticity and sensory loss in the stroke participants.The relationship between walking (speed and capacity) and coordination (total scores of LEMOCOT; the amplitude and jerk of lower limb movement) will be analysed and compared between groups.
Their usual physiotherapy intervention and rehab program will not be influenced by participating in this project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50366 0
Ms May Suk-Man Kwan
Address 50366 0
Department of Physiotherapy, Royal Prince Alfred Hospital, Level 5, QEII Building, 57-59 Missenden Road, Camperdown 2050. NSW Australia
Country 50366 0
Australia
Phone 50366 0
+612 9515 9850
Fax 50366 0
Email 50366 0
[email protected]
Contact person for public queries
Name 50367 0
Ms May Suk-Man Kwan
Address 50367 0
Department of Physiotherapy, Royal Prince Alfred Hospital, Level 5, QEII Building, 57-59 Missenden Road, Camperdown 2050. NSW Australia
Country 50367 0
Australia
Phone 50367 0
+612 9515 9850
Fax 50367 0
Email 50367 0
[email protected]
Contact person for scientific queries
Name 50368 0
Prof Louise Ada
Address 50368 0
Discipline of Physiotherapy
FACULTY OF HEALTH SCIENCES
The University of Sydney
75 East Street
Lidcombe 2141
NSW
Country 50368 0
Australia
Phone 50368 0
+61 2 9351 9544
Fax 50368 0
Email 50368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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