Cerebral PalsyNCT02467829
Effects of Altering Handle Height of Posterior Walkers
A study testing Increase in handle height in people with Cerebral Palsy, run by University of Birmingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Increase in handle height
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Kinesiology Laboratory
Birmingham, West Midlands, B15 2TT
François-Xavier Li, PhD, 0121 414 4114, F.X.Li@bham.ac.uk
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Increase in handle height
- Keywords
- Cerebral Palsy, Walking Aids
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase in handle heightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 10° of elbow flexion | No intervention | 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. |
| 30° of elbow flexion | Experimental | Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 30° of elbow flexion. Receives: Device: Increase in handle height |
| 50° of elbow flexion | Experimental | Increase in handle height. This handle height is the nearest position the walker can be set to to achieve 50° of elbow flexion. Receives: Device: Increase in handle height |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Half a day
Secondary outcomes (6)
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.
Measured: Half a day
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.
Measured: Half a day
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.
Measured: Half a day
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.
Measured: 1-2 hours
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).
Measured: 10 mins
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.
Measured: 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyn Poole, BSc, Principal investigator, Birmingham Community Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467829
- Sponsor's protocol ID
- RG_15-057
- Status last verified
- Jan 2016
- First submitted
- 5 Jun 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8466419Logan 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.
PubMed 2149558Mattsson 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.
PubMed 9352728Park 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.
PubMed 11371104Konop 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.
PubMed 19616952Konop 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.
PubMed 19448356Tomlinson 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.
PubMed 20921070Raja 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.
PubMed 17314635Ketelaar 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.
PubMed 9796927
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Effects of Altering Handle Height of Posterior Walkers on Gait Parameters in Children With Spastic Cerebral Palsy?
- ClinicalTrials.gov ID
- NCT02467829
- Acronym / sponsor ID
- RG_15-057
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Walking Aids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10° of elbow flexion | No intervention | –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. |
| 30° of elbow flexion | Experimental | Device: Increase in handle heightIncrease in handle height. This handle height is the nearest position the walker can be set to to achieve 30° of elbow flexion. |
| 50° of elbow flexion | Experimental | Device: Increase in handle heightIncrease in handle height. This handle height is the nearest position the walker can be set to to achieve 50° of elbow flexion. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increase in handle heightElbow 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. | Device | 30° of elbow flexion, 50° of elbow flexion |
Primary outcome
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.
6 secondary outcomes
Force through the legs of the walker and the participants feet.
Time frame: Half a day
Physiological cost index
Time frame: Half a day
The Faces Pain Scale -Revised
Time frame: Half a day
Gross Motor function measure - 88
Time frame: 1-2 hours
Hip abductor strength
Time frame: 10 mins
Posterior walker 180 degree turn test
Time frame: 5 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Background: PubMed 8466419Greiner 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.
- Background: PubMed 2149558Logan 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.
- Background: PubMed 9352728Mattsson 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.
- Background: PubMed 11371104Park 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.
- Background: PubMed 19616952Konop 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.
- Background: PubMed 19448356Konop 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.
- Background: PubMed 20921070Tomlinson 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.
- Background: PubMed 17314635Raja 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.
- Background: PubMed 9796927Ketelaar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Poole, BSc principal investigator
Birmingham Community Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase in handle height in people with Cerebral Palsy, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François-Xavier Li, PhD (+441214144121, f.x.li@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three dimensional gait analysis (time frame: Half a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467829, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.