Effects of Altering Handle Height of Posterior Walkers

January 7, 2016 updated by: University of Birmingham

What Are the Effects of Altering Handle Height of Posterior Walkers on Gait Parameters in Children With Spastic Cerebral Palsy?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
        • Recruiting
        • Kinesiology Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 10° of elbow flexion
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.
Experimental: 30° of elbow flexion
Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 30° of elbow flexion.
Device: Increase in handle height
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.
Experimental: 50° 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.
Device: Increase in handle height
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three dimensional gait analysis
Time Frame: Half a day
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.
Half a day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force through the legs of the walker and the participants feet.
Time Frame: Half a day
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.
Half a day
Physiological cost index
Time Frame: Half a day

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.
Half a day
The Faces Pain Scale -Revised
Time Frame: Half a day
The participant chooses from one of 5 faces to indicate how much pain they are in. This will be repeated at each handle height.
Half a day
Gross Motor function measure - 88
Time Frame: 1-2 hours
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.
1-2 hours
Hip abductor strength
Time Frame: 10 mins
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).
10 mins
Posterior walker 180 degree turn test
Time Frame: 5 mins
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.
5 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Investigators

  • Principal Investigator: Marilyn Poole, BSc, Birmingham Community Healthcare NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_15-057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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