- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07636135
Timing of Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy
Feasibility of Early Post-operative Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy
The goal of this clinical trial is to learn whether starting rehabilitation earlier after surgery can improve recovery and is feasible and acceptable for adults with degenerative cervical myelopathy (DCM) undergoing cervical spine surgery. The main question it aims to answer is:
Does starting rehabilitation earlier improve walking, balance, physical activity, quality of life, and nervous system function after surgery?
Researchers will compare participants who begin rehabilitation two weeks after surgery with participants who begin rehabilitation six weeks after surgery to see if earlier rehabilitation leads to better recovery outcomes and participation.
Participants will:
Be randomly assigned to begin rehabilitation either two weeks or six weeks after surgery.
Attend physical therapy sessions twice per week for eight weeks focused on strength, balance, and walking.
Complete assessments of walking ability, balance, physical activity, quality of life, and nervous system function over several months after surgery.
Provide feedback about their experience with the rehabilitation program, including satisfaction and any side effects or challenges related to participation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult (>18 years of age) with diagnosis of degenerative cervical myelopathy, within 2 weeks of spinal decompression surgery
- plan to be discharged home from acute care (i.e., not admitted to another facility for post-operative rehabilitation)
- able to stand with a maximum of one-person assist (+/- use of gait aid)
- persistent functional impairment in lower extremity strength, balance, coordination, and/or gait
- ability to attend an 8-week in-person rehabilitation program in Edmonton, Alberta
Exclusion Criteria:
- discharge from acute care facility > 2 weeks post-operative
- intra-operative or early post-operative complication delaying discharge or precluding participation in early rehabilitation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care Rehabilitation
Participants will begin post-operative rehabilitation 6 weeks following their cervical spine surgery
|
Active, task-specific physical therapy to enhance balance, walking, and strength
|
|
Experimental: Early Rehabilitation
Participants will begin post-operative rehabilitation 2 weeks following their cervical spine surgery
|
Active, task-specific physical therapy to enhance balance, walking, and strength
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Ten Metre Walk Test
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Time to walk ten metres; lower times indicate faster walking speed
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Six Minute Walk Test
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Distance walked in six minutes; longer distances indicate greater walking endurance
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
|
Change from Baseline in the Timed Up and Go
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Time taken to stand, walk 3 metres and return to sitting position; longer time indicates balance and mobility impairments
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
|
Change from Baseline in the Berg Balance Scale
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Standardized test that includes 14 balance tasks, with scores ranging from 0 to 56; lower scores indicate balance impairment
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
|
Change from Baseline on the 36-item Short Form Survey
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Survey measuring health-related quality of life, with scores ranging from 0 to 100; higher scores indicate better health status
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
|
Change from Admission to Study on the modified Japanese Orthopaedic Association Scale
Time Frame: Study Admission and End of Study (12 weeks)
|
Score to evaluate the severity of degenerative cervical myelopathy, with scores ranging from 0 to 18; higher scores indicate more mild myelopathy
|
Study Admission and End of Study (12 weeks)
|
|
Change from Baseline in Motor-Evoked Potentials
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Transcranial Magnetic Stimulation (TMS) will be used and electromyography (EMG) will be recorded in lower extremity muscles; size of motor-evoked potentials will be measured
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
|
Change from Baseline in Hoffman Reflexes
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Hoffman reflexes will be elicited in the soleus muscle and electromyography (EMG) will be recorded; H:M ratios and rate-dependent depression will be measured.
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility (Participant Recruitment and Retention)
Time Frame: From Study Admission to the End of Study (12 weeks)
|
The recruitment and drop out rates will be recorded
|
From Study Admission to the End of Study (12 weeks)
|
|
Acceptability
Time Frame: Immediately following rehabilitation (Week 8 for Intervention Group, Week 12 for Usual Care Control)
|
Participants will describe their satisfaction with the intervention (including content and timing) through a custom survey following the intervention
|
Immediately following rehabilitation (Week 8 for Intervention Group, Week 12 for Usual Care Control)
|
|
Safety (Adverse Events)
Time Frame: From Study Admission to the End of Study (12 weeks)
|
Details and timing of any adverse events will be documented for all participants
|
From Study Admission to the End of Study (12 weeks)
|
|
Change from Baseline in Daily Activity
Time Frame: Baseline and End Rehabilitation (8 weeks following Baseline)
|
Activity monitors will be used to measure daily activity levels (including step counts).
Average activity over 4-7 days of monitoring will be calculated.
|
Baseline and End Rehabilitation (8 weeks following Baseline)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00161798
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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