Effects of Altering Handle Height of Posterior Walkers

NCT02467829 | Unknown

• 1 other identifier: RG_15-057
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Walking Aids

Outcome Measures

Primary Outcomes (1)

• 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.

  Half a day

Secondary Outcomes (6)

• Force through the legs of the walker and the participants feet.

  Half a day

• Physiological cost index

  Half a day

• The Faces Pain Scale -Revised

  Half a day

• Gross Motor function measure - 88

  1-2 hours

• Hip abductor strength

  10 mins

Study Arms (3)

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.

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.

Device: Increase in handle height

Interventions

Increase in handle height DEVICE

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.

30° of elbow flexion; 50° of elbow flexion

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

Kinesiology Laboratory

Birmingham, West Midlands, B15 2TT, United Kingdom

RECRUITING

Related Publications (9)

• 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.

  PMID: 8466419 BACKGROUND

• 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.

  PMID: 2149558 BACKGROUND

• 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.

  PMID: 9352728 BACKGROUND

• 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.

  PMID: 11371104 BACKGROUND

• 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.

  PMID: 19616952 BACKGROUND

• 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.

  PMID: 19448356 BACKGROUND

• 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.

  PMID: 20921070 BACKGROUND

• 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.

  PMID: 17314635 BACKGROUND

• 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.

  PMID: 9796927 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Marilyn Poole, BSc

  Birmingham Community Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François-Xavier Li, PhD

CONTACT

+441214144121; f.x.li@bham.ac.uk

Doug Simkiss

CONTACT

+441214666442; d.simkiss@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 10, 2015
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

GB (1)