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Individualised Gait Modification Strategies in Alkaptonuria Patients

Determining Individualised Gait Modification Strategies to Reduce Knee Joint Moments in Alkaptonuria Patients Using Real-time Feedback

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04142671
Enrollment
30
Registered
2019-10-29
Start date
2021-10-31
Completion date
2022-10-31
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alkaptonuria

Brief summary

This study evaluates the efficacy of a gait modification intervention using real-time biofeedback on reducing the knee joint loading in Alkaptonuria patients during treadmill walking. It will also assess whether the individualised adopted gait modification can be retained without feedback and during over ground walking.

Detailed description

Alkaptonuria (AKU) is a degenerative disease affecting the cartilage of the joints. The disease affects movement function, particularly walking/gait which is an important activity of daily living. It is believed that increased joint loading measured by the moments acting upon the joints, contributes to the degeneration of joint cartilage in Alkaptonuria, particularly in the weight bearing joints such as the knee and hips, resulting in accelerated progression of painful symptoms. Currently there is no cure for Alkaptonuria and the current management includes joint replacement surgery. Gait modification strategy interventions could be a non-invasive alternative which could delay the time to surgical interventions by reducing or altering joint loading and stalling the progression of disease. The aims of this study are 1) to determine if individualised gait modification strategies can be used to reduce the 3D knee joint loading, 2) to determine if the gait modifications can be retained without feedback during over ground walking and 3) to determine the individualised gait modification strategies adopted by AKU patients. Gait data will be measured and quantified using the non-invasive typical clinical gait analysis set up, using 3D motion capture combined with force data whereby joint angles, moments and powers can be calculated in all 3 planes of motion during treadmill walking. The intervention will involve real-time biofeedback using Motek's M-Gait treadmill. Due to the heterogeneity of the sample, each AKU patient will act as their own control. Gait data will be compared pre- and post-intervention and a validated pain score will be used to identify any patterns with knee pain and adopted gait modifications.

Interventions

OTHERIndividualised gait modification intervention

An individualised gait modification intervention to reduce knee joint loading. Knee joint loading will be presented in real-time during treadmill walking. A 10% reduction of each patients baseline knee loading will be used as a target threshold along with visualisation of the history of 5 previous steps. Patients are encouraged to determine their own gait modification strategy that is most efficient for them. Previous examples of gait modifications that mechanically reduce knee loading will be presented to them.

Sponsors

Liverpool University Hospitals NHS Foundation Trust
CollaboratorOTHER_GOV
Liverpool John Moores University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Single group trial pre- post-intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* The diagnosis of Alkaptonuria * Able to understand written and spoken English. * Willing and able to give informed consent to participate * Above the age of 18.

Exclusion criteria

* The reliance on or use of a walking aid. * Any previous lower limb joint replacements. * Any severe pain or unable to walk comfortably and consecutively for 20 minutes. * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline 3D knee joint moment impulse after interventionAt baseline and immediately after the interventionThis represents the knee joint load during walking measured from kinematic and kinetic data obtained during the 3D gait analysis

Secondary

MeasureTime frameDescription
Change from baseline joint angles after interventionAt baseline and immediately after the interventionLower limb joint angles in degrees measured from kinematic data obtained during the 3D gait analysis
Change from baseline joint moments after interventionAt baseline and immediately after the interventionLower limb joint moments in Nm/kg measured from kinematic and kinetic data obtained during the 3D gait analysis
Change from baseline joint powers after interventionAt baseline and immediately after the interventionLower limb joint powers in Watts/kg measured from kinematic and kinetic data obtained during the 3D gait analysis
Knee injury and Osteoarthritis Outcome ScorePre-interventionValidated Knee injury and Osteoarthritis Outcome Score Questionnaire. Scores between 0-100, 0 representing extreme problems and 100 representing no problems.

Contacts

Primary ContactHannah H Shepherd
H.R.Shepherd@ljmu.ac.uk+447711490847

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026