Individualised Gait Modification Strategies in Alkaptonuria Patients

NCT04142671 | Unknown

• 2 other identifiers: 19LJMUSPONSOR086248641
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alkaptonuria

Outcome Measures

Primary Outcomes (1)

• Change from baseline 3D knee joint moment impulse after intervention

  This represents the knee joint load during walking measured from kinematic and kinetic data obtained during the 3D gait analysis

  At baseline and immediately after the intervention

Secondary Outcomes (4)

• Change from baseline joint angles after intervention

  At baseline and immediately after the intervention

• Change from baseline joint moments after intervention

  At baseline and immediately after the intervention

• Change from baseline joint powers after intervention

  At baseline and immediately after the intervention

• Knee injury and Osteoarthritis Outcome Score

  Pre-intervention

Study Arms (1)

Individualised Gait Modification Intervention

EXPERIMENTAL

Patients will carry out several walking trials to test the efficacy of an individualised gait modification intervention. Pre-intervention over ground walking, pre-intervention treadmill walking, intervention treadmill walking with real-time biofeedback on their knee loading, intervention treadmill walking with no feedback, and post-intervention over ground walking.

Other: Individualised gait modification intervention

Interventions

Individualised gait modification intervention OTHER

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.

Individualised Gait Modification Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Related Publications (2)

• Simic M, Hinman RS, Wrigley TV, Bennell KL, Hunt MA. Gait modification strategies for altering medial knee joint load: a systematic review. Arthritis Care Res (Hoboken). 2011 Mar;63(3):405-26. doi: 10.1002/acr.20380. Epub 2010 Oct 27.

  PMID: 20981808 BACKGROUND

• Taylor AM, Boyde A, Wilson PJ, Jarvis JC, Davidson JS, Hunt JA, Ranganath LR, Gallagher JA. The role of calcified cartilage and subchondral bone in the initiation and progression of ochronotic arthropathy in alkaptonuria. Arthritis Rheum. 2011 Dec;63(12):3887-96. doi: 10.1002/art.30606.

  PMID: 22127706 BACKGROUND

MeSH Terms

Conditions

Alkaptonuria

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gabor J Barton, MD, PhD

  Liverpool John Moores University

  STUDY DIRECTOR

Central Study Contacts

Hannah H Shepherd

CONTACT

+447711490847; H.R.Shepherd@ljmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Lecturer in Clinical Biomechanics

Model Details: Single group trial pre- post-intervention

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share