MoveMed in Clinical Trials: Advancing Research in Degenerative Cervical Myelopathy

The Challenge

Degenerative Cervical Myelopathy (DCM) is a common condition affecting up to 2% of adults worldwide, caused by arthritic changes in the neck that compress the spinal cord. This compression leads to progressive neurological decline, including numb and clumsy hands, imbalance, frequent falls, and bladder problems. Without treatment, DCM can progress to severe disability and paralysis.

Clinical trials for DCM face significant challenges in accurately measuring patient outcomes, particularly in:

• Objectively quantifying subtle neurological changes over time
• Collecting consistent, standardized data across multiple trial sites
• Reducing patient burden in trials requiring long-term follow-up
• Generating sensitive measures that can detect meaningful clinical changes with smaller sample sizes

Traditional outcome assessments rely heavily on intermittent clinic visits and subjective patient-reported measures, which may miss important changes in patient function between appointments and introduce variability that can obscure treatment effects.

The MoveMed Solution

MoveMed has been implemented as a key digital assessment tool in two major NIHR-funded phase 3 randomized controlled trials for DCM:

POLYFIX-DCM Trial

This trial compares laminectomy alone versus laminectomy with fusion in 394 patients with DCM, seeking to determine which surgical approach leads to better recovery.

RECEDE-Myelopathy Trial

The first regenerative treatment trial for DCM, testing Ibudilast as an adjuvant to decompressive surgery in a multi-center, double-blind, placebo-controlled study.

MoveMed provides these trials with:

• Objective Digital Biomarkers: The app’s battery of tests deliver quantifiable metrics of upper and lower limb function that directly relate to DCM severity
• Remote Monitoring Capability: Patients can complete assessments at home between scheduled visits, creating a more comprehensive picture of recovery
• Standardized Assessment: Uniform testing protocols ensure consistent data collection across all trial sites
• Enhanced Sensitivity: Digital measures can detect subtle changes in neurological function that might be missed by traditional clinical scales

Implementation Details

The implementation of MoveMed in these trials demonstrates several key advantages:

• Patient-Centered Design: The simple smartphone-based interface allows patients to complete assessments in their own environment with minimal burden
• Seamless Integration: MoveMed data flows directly into the trial databases, reducing administrative overhead and potential for transcription errors
• Multi-Site Consistency: All participating centers use identical testing protocols through the MoveMed platform, enhancing data quality
• Longitudinal Tracking: Regular remote assessments create more complete recovery trajectories for each participant

The Impact

While these trials are ongoing, early implementation of MoveMed has demonstrated:

1. Enhanced Data Resolution: More frequent assessment points are providing a clearer picture of recovery trajectories
2. Improved Patient Retention: The reduced burden of remote assessment is helping maintain high follow-up rates
3. Novel Insights: Digital measures are capturing aspects of recovery not evident through traditional assessments
4. Statistical Power: The precision of digital measures may enable detection of treatment effects with greater sensitivity

Trial investigators recognise the value of incorporating digital outcome measures in these landmark studies to advance understanding of DCM treatments and recovery patterns.

Looking Forward

The integration of MoveMed into these prestigious NIHR-funded clinical trials represents a significant advancement in clinical trial methodology. As these trials progress, MoveMed continues to evolve with:

• Ongoing refinement of digital biomarkers specific to DCM
• Development of machine learning algorithms to identify patterns predictive of treatment response
• Expansion of application to other conditions affecting movement such as neurological, musculoskeletal and cardiovascular conditions
• Continued validation against established clinical measures

Why Choose MoveMed for Clinical Trials?

• Evidence-Based: Built on validated digital biomarkers with established reliability and validity
• Regulatory-Aligned: Designed following FDA and EMA guidance for digital endpoints
• Flexible Implementation: Adaptable to various trial designs and clinical conditions
• Patient-Friendly: Minimal training requirements with high compliance rates
• Data Security: Compliant with international data protection standards
• Scientific Support: Backed by a team of clinical and digital health experts

The successful implementation of MoveMed in these pivotal DCM trials demonstrates its potential value across a wide range of clinical research applications where objective, remote measurement of physical function is needed.

We welcome researchers, pharmaceutical companies, and medical device manufacturers to contact us for a free consultation on how MoveMed can enhance your clinical trial or research projects.

References

POLYFIX-DCM Trial. Cambridge Clinical Trials Unit. https://cctu.org.uk/portfolio/surgical-peri-operative-care/trials-open-to-recruitment/polyfix-dcm

RECEDE-Myelopathy Trial. Cambridge Clinical Trials Unit. https://cctu.org.uk/portfolio/surgical-peri-operative-care/trials-open-to-recruitment/recede-myelopathy