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| Name | Class |
|---|---|
| Alberta Spine Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Rehabilitation | Active Comparator | Participants will begin post-operative rehabilitation 6 weeks following their cervical spine surgery |
|
| Early Rehabilitation | Experimental | Participants will begin post-operative rehabilitation 2 weeks following their cervical spine surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Behavioral | Active, task-specific physical therapy to enhance balance, walking, and strength |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Ten Metre Walk Test | Time to walk ten metres; lower times indicate faster walking speed | Baseline and End Rehabilitation (8 weeks following Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Six Minute Walk Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (Participant Recruitment and Retention) | The recruitment and drop out rates will be recorded | From Study Admission to the End of Study (12 weeks) |
| Acceptability | Participants will describe their satisfaction with the intervention (including content and timing) through a custom survey following the intervention |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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 | 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 | 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 | 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 | 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 | 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) |
| Immediately following rehabilitation (Week 8 for Intervention Group, Week 12 for Usual Care Control) |
| Safety (Adverse Events) | 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 | 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) |
| D014947 | Wounds and Injuries |