Effects of Altering Handle Height of Posterior Walkers

University of Birmingham

Status: Unknown

Conditions: Cerebral Palsy

Treatments: Device: Increase in handle height

Study type: Interventional

Funder types: Other

Identifiers

NCT02467829

RG_15-057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

10° of elbow flexion

No Intervention group

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.

30° of elbow flexion

Experimental group

Description:

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

Treatment:

Device: Increase in handle height

50° of elbow flexion

Experimental group

Description:

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

Treatment:

Device: Increase in handle height