AlkaptonuriaNCT04142671
Individualised Gait Modification Strategies in Alkaptonuria Patients
A study testing Individualised gait modification intervention in people with Alkaptonuria, run by Liverpool John Moores University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alkaptonuria
- What is being tested?
- Individualised gait modification intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determining Individualised Gait Modification Strategies to Reduce Knee Joint Moments in Alkaptonuria Patients Using Real-time Feedback
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.
Read the 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.
- Conditions
- Alkaptonuria
- Being tested
- Individualised gait modification intervention
- Medical subject headings
- Alkaptonuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised gait modification interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Individualised gait modification intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and immediately after the intervention
Secondary outcomes (4)
Change from baseline joint angles after intervention
Lower limb joint angles in degrees measured from kinematic data obtained during the 3D gait analysis
Measured: At baseline and immediately after the intervention
Change from baseline joint moments after intervention
Lower limb joint moments in Nm/kg measured from kinematic and kinetic data obtained during the 3D gait analysis
Measured: At baseline and immediately after the intervention
Change from baseline joint powers after intervention
Lower limb joint powers in Watts/kg measured from kinematic and kinetic data obtained during the 3D gait analysis
Measured: At baseline and immediately after the intervention
Knee injury and Osteoarthritis Outcome Score
Validated Knee injury and Osteoarthritis Outcome Score Questionnaire. Scores between 0-100, 0 representing extreme problems and 100 representing no problems.
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AlkaptonuriaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group trial pre- post-intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Hannah Shepherd, Liverpool John Moores University
- Investigators
- Gabor J Barton, MD, PhD, Study director, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142671
- Sponsor's protocol ID
- 19LJMUSPONSOR086
- Other IDs
- 248641
- Status last verified
- Feb 2021
- First submitted
- 24 Oct 2019
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
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.
PubMed 20981808Taylor 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.
PubMed 22127706
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Individualised Gait Modification Strategies to Reduce Knee Joint Moments in Alkaptonuria Patients Using Real-time Feedback
- ClinicalTrials.gov ID
- NCT04142671
- Acronym / sponsor ID
- 19LJMUSPONSOR086
- Conditions
- Alkaptonuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Oct 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group trial pre- post-intervention
| Arm | Type | Receives |
|---|---|---|
| Individualised Gait Modification Intervention | Experimental | Other: Individualised gait modification interventionPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Individualised gait modification interventionAn 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. | Other | Individualised Gait Modification Intervention |
Primary outcome
Change from baseline 3D knee joint moment impulse after intervention
Time frame: At baseline and immediately after the intervention
This represents the knee joint load during walking measured from kinematic and kinetic data obtained during the 3D gait analysis
4 secondary outcomes
Change from baseline joint angles after intervention
Time frame: At baseline and immediately after the intervention
Change from baseline joint moments after intervention
Time frame: At baseline and immediately after the intervention
Change from baseline joint powers after intervention
Time frame: At baseline and immediately after the intervention
Knee injury and Osteoarthritis Outcome Score
Time frame: Pre-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Background: PubMed 20981808Simic 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.
- Background: PubMed 22127706Taylor 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
Related trials for Alkaptonuria
RecruitingObservational study
Study of Alkaptonuria
Alkaptonuria
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.
Gabor J Barton, MD, PhD study director
Liverpool John Moores University
Questions about this trial
What is this clinical trial studying?
A study testing Individualised gait modification intervention in people with Alkaptonuria, run by Liverpool John Moores University.
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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Hannah H Shepherd (+447711490847, H.R.Shepherd@ljmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline 3D knee joint moment impulse after intervention (time frame: At baseline and immediately after the intervention). 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 NCT04142671, which also lists 2 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 26 Feb 2021.