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Effects of Altering Handle Height of Posterior Walkers

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Increase in handle height
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring Cerebral Palsy, Walking Aids

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of spastic Cerebral Palsy by a medical practitioner from clinical presentation.
  • Aged 5-18 years.
  • Able to walk 50m with a posterior walker without rest.
  • Uses a posterior walker at least once a week.

Exclusion Criteria:

  • Aged below 5 years or over 18.
  • Orthopaedic surgery in the last 6 months, serial casting or botulinum toxin injections in the 12 weeks prior to or during the study, as gait could vary significantly following these interventions.
  • Unable to walk 50m in a straight line and follow verbal prompts to turn.
  • Insufficient understanding, in the opinion of their carer or therapist, to complete Faces rating scale.

Sites / Locations

  • Kinesiology LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

10° of elbow flexion

30° of elbow flexion

50° of elbow flexion

Arm Description

This handle height is the nearest position the walker can be set to to achieve 10° of elbow flexion. Elbow flexion is measured with the child standing in their walker using an electronic goniometer.

Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 30° of elbow flexion.

Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 50° of elbow flexion.

Outcomes

Primary Outcome Measures

Three dimensional gait analysis
Kinetic data will be captured using a 13 camera Vicon three dimensional motion analysis system. Reflective markers will be placed bilaterally on the acromion process, lateral epicondyle of the elbow, styloid process of the ulna, greater trochanter of the femur, anterior superior iliac spine, posterior superior iliac spine, lateral epicondyle of the femur, lateral malleolus, insertion of the achilles tendon and head of the fifth metatarsal. Markers will be placed on the corners of walker, at the top and bottom of it (8 in total). Trunk hip and knee angles on both sides of the body will be recorded throughout the gait cycle, as children with CP often have asymmetrical gait. Velocity, step and stride length and double support time will also be calculated using this system.

Secondary Outcome Measures

Force through the legs of the walker and the participants feet.
A sensor will be placed in each of the four walker legs to measure the force going through each one. The force the participants's feet exert on the floor will be measured as they cross the force plate.
Physiological cost index
This measures efficiency of gait in beats per metre.It is calculated using the following formula: Walking heart rate-resting heart rate/walking speed. Heart rate is measured in beats/minute and speed in metres/minute. Heart rate will be continuously monitored electronically. It will be calculated over a distance of 50m.
The Faces Pain Scale -Revised
The participant chooses from one of 5 faces to indicate how much pain they are in. This will be repeated at each handle height.
Gross Motor function measure - 88
Used to assess change in gross motor function over time in children with CP. Participants are asked to do a series of simple tasks across 5 domains of lying and rolling, sitting, crawling and kneeling, standing, walking running and jumping.
Hip abductor strength
Hip abductor strength will be measured in supine lying using a Kin Com dynamometer, as previously described by Engsberg at al (Engsberg et al., 2002).
Posterior walker 180 degree turn test
This test has been designed for the purposes of this study. A line is taped on the floor perpendicular to the direction in which the participant is walking. They approach the line from a minimum of 3m away and turn when they reach the line. Direction of the turn (clockwise/anticlockwise), time and number of steps taken to turn 180 degrees is recorded.

Full Information

First Posted
June 5, 2015
Last Updated
January 7, 2016
Sponsor
University of Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02467829
Brief Title
Effects of Altering Handle Height of Posterior Walkers
Official Title
What Are the Effects of Altering Handle Height of Posterior Walkers on Gait Parameters in Children With Spastic Cerebral Palsy?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aims of this study are to investigate what effect altering handle height of posterior walkers has on forces through the walker, posture, efficiency, stability, speed, turning and comfort, and to obtain data which helps therapists understand the bio-mechanics involved during use and if this alters depending on age, posture or strength. All participants will have cerebral palsy. This will allow informed prescription of walkers and identify potential for redesign to improve efficiency, promote strengthening or improve posture to maximise children's potential to continue functional walking into adulthood.
Detailed Description
Children with cerebral palsy (CP) find walking effortful due to weakness, lack of coordination between muscle groups, postural changes, poor balance and altered muscle tone. Walking aids improve efficiency, stability and posture.Posterior walkers were developed in the mid 1980's. There is evidence of their advantages over more traditional anterior walkers, however there is no evidence relating to setting handle height, and little information about bio-mechanics during use. This is a quantitative pilot study with a cross over design. A purposive sample of approximately 15 children will be recruited from Birmingham Community Healthcare National Health Service (NHS) Trust. Assessments will be carried out at 3 different handle heights, determined by measuring elbow flexion when the participant is standing holding the handles of their walker. Participants will attend two assessments. One at their school, and a second at the University of Birmingham. Forces going through the walker and the participant's feet, range of motion at the trunk, hip and knee, velocity, step and stride length, double support time, physiological cost index, pain, gross motor function, hip abductor strength and ease of turning will be measured. Analysis of variance with repeated measures will be used to analyse changes across handle heights and multiple linear regression to show associations between the dependent variables studied and identify potential confounding factors. p<0.05 will be considered statistically significant. Effect sizes needed for clinical significance will be considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Walking Aids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10° of elbow flexion
Arm Type
No Intervention
Arm Description
This handle height is the nearest position the walker can be set to to achieve 10° of elbow flexion. Elbow flexion is measured with the child standing in their walker using an electronic goniometer.
Arm Title
30° of elbow flexion
Arm Type
Experimental
Arm Description
Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 30° of elbow flexion.
Arm Title
50° of elbow flexion
Arm Type
Experimental
Arm Description
Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 50° of elbow flexion.
Intervention Type
Device
Intervention Name(s)
Increase in handle height
Intervention Description
Elbow flexion is measured with the child standing in their walker using an electronic goniometer. Approximately 10° of elbow flexion is current recommended practice. 30° and 50° are increased handle heights.
Primary Outcome Measure Information:
Title
Three dimensional gait analysis
Description
Kinetic data will be captured using a 13 camera Vicon three dimensional motion analysis system. Reflective markers will be placed bilaterally on the acromion process, lateral epicondyle of the elbow, styloid process of the ulna, greater trochanter of the femur, anterior superior iliac spine, posterior superior iliac spine, lateral epicondyle of the femur, lateral malleolus, insertion of the achilles tendon and head of the fifth metatarsal. Markers will be placed on the corners of walker, at the top and bottom of it (8 in total). Trunk hip and knee angles on both sides of the body will be recorded throughout the gait cycle, as children with CP often have asymmetrical gait. Velocity, step and stride length and double support time will also be calculated using this system.
Time Frame
Half a day
Secondary Outcome Measure Information:
Title
Force through the legs of the walker and the participants feet.
Description
A sensor will be placed in each of the four walker legs to measure the force going through each one. The force the participants's feet exert on the floor will be measured as they cross the force plate.
Time Frame
Half a day
Title
Physiological cost index
Description
This measures efficiency of gait in beats per metre.It is calculated using the following formula: Walking heart rate-resting heart rate/walking speed. Heart rate is measured in beats/minute and speed in metres/minute. Heart rate will be continuously monitored electronically. It will be calculated over a distance of 50m.
Time Frame
Half a day
Title
The Faces Pain Scale -Revised
Description
The participant chooses from one of 5 faces to indicate how much pain they are in. This will be repeated at each handle height.
Time Frame
Half a day
Title
Gross Motor function measure - 88
Description
Used to assess change in gross motor function over time in children with CP. Participants are asked to do a series of simple tasks across 5 domains of lying and rolling, sitting, crawling and kneeling, standing, walking running and jumping.
Time Frame
1-2 hours
Title
Hip abductor strength
Description
Hip abductor strength will be measured in supine lying using a Kin Com dynamometer, as previously described by Engsberg at al (Engsberg et al., 2002).
Time Frame
10 mins
Title
Posterior walker 180 degree turn test
Description
This test has been designed for the purposes of this study. A line is taped on the floor perpendicular to the direction in which the participant is walking. They approach the line from a minimum of 3m away and turn when they reach the line. Direction of the turn (clockwise/anticlockwise), time and number of steps taken to turn 180 degrees is recorded.
Time Frame
5 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of spastic Cerebral Palsy by a medical practitioner from clinical presentation. Aged 5-18 years. Able to walk 50m with a posterior walker without rest. Uses a posterior walker at least once a week. Exclusion Criteria: Aged below 5 years or over 18. Orthopaedic surgery in the last 6 months, serial casting or botulinum toxin injections in the 12 weeks prior to or during the study, as gait could vary significantly following these interventions. Unable to walk 50m in a straight line and follow verbal prompts to turn. Insufficient understanding, in the opinion of their carer or therapist, to complete Faces rating scale.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François-Xavier Li, PhD
Phone
+441214144121
Email
f.x.li@bham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Doug Simkiss
Phone
+441214666442
Email
d.simkiss@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn Poole, BSc
Organizational Affiliation
Birmingham Community Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinesiology Laboratory
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François-Xavier Li, PhD
Phone
0121 414 4114
Email
F.X.Li@bham.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
8466419
Citation
Greiner BM, Czerniecki JM, Deitz JC. Gait parameters of children with spastic diplegia: a comparison of effects of posterior and anterior walkers. Arch Phys Med Rehabil. 1993 Apr;74(4):381-5.
Results Reference
background
PubMed Identifier
2149558
Citation
Logan L, Byers-Hinkley K, Ciccone CD. Anterior versus posterior walkers: a gait analysis study. Dev Med Child Neurol. 1990 Dec;32(12):1044-8. doi: 10.1111/j.1469-8749.1990.tb08521.x.
Results Reference
background
PubMed Identifier
9352728
Citation
Mattsson E, Andersson C. Oxygen cost, walking speed, and perceived exertion in children with cerebral palsy when walking with anterior and posterior walkers. Dev Med Child Neurol. 1997 Oct;39(10):671-6. doi: 10.1111/j.1469-8749.1997.tb07361.x.
Results Reference
background
PubMed Identifier
11371104
Citation
Park ES, Park CI, Kim JY. Comparison of anterior and posterior walkers with respect to gait parameters and energy expenditure of children with spastic diplegic cerebral palsy. Yonsei Med J. 2001 Apr;42(2):180-4. doi: 10.3349/ymj.2001.42.2.180.
Results Reference
background
PubMed Identifier
19616952
Citation
Konop KA, Strifling KM, Wang M, Cao K, Schwab JP, Eastwood D, Jackson S, Ackman JD, Harris GF. A biomechanical analysis of upper extremity kinetics in children with cerebral palsy using anterior and posterior walkers. Gait Posture. 2009 Oct;30(3):364-9. doi: 10.1016/j.gaitpost.2009.06.012. Epub 2009 Jul 18.
Results Reference
background
PubMed Identifier
19448356
Citation
Konop KA, Strifling KM, Wang M, Cao K, Eastwood D, Jackson S, Ackman J, Altiok H, Schwab J, Harris GF. [Upper extremity kinetics and energy expenditure during walker-assisted gait in children with cerebral palsy]. Acta Orthop Traumatol Turc. 2009 Mar-Apr;43(2):156-64. doi: 10.3944/AOTT.2009.156. Turkish.
Results Reference
background
PubMed Identifier
20921070
Citation
Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
Results Reference
background
PubMed Identifier
17314635
Citation
Raja K, Joseph B, Benjamin S, Minocha V, Rana B. Physiological cost index in cerebral palsy: its role in evaluating the efficiency of ambulation. J Pediatr Orthop. 2007 Mar;27(2):130-6. doi: 10.1097/01.bpb.0000242440.96434.26.
Results Reference
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PubMed Identifier
9796927
Citation
Ketelaar M, Vermeer A, Helders PJ. Functional motor abilities of children with cerebral palsy: a systematic literature review of assessment measures. Clin Rehabil. 1998 Oct;12(5):369-80. doi: 10.1191/026921598673571117.
Results Reference
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Effects of Altering Handle Height of Posterior Walkers

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