Cervical Myelopathy
Conditions
Keywords
physical therapy, post-operative rehabilitation, walking, degenerative cervical myelopathy, spinal cord injury
Brief summary
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.
Interventions
BEHAVIORALPhysical Therapy
Active, task-specific physical therapy to enhance balance, walking, and strength
Sponsors
University of Alberta
Alberta Spine Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Ten Metre Walk Test | Baseline and End Rehabilitation (8 weeks following Baseline) | Time to walk ten metres; lower times indicate faster walking speed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Six Minute Walk Test | Baseline and End Rehabilitation (8 weeks following Baseline) | Distance walked in six minutes; longer distances indicate greater walking endurance |
| Change from Baseline in the Timed Up and Go | 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 |
| Change from Baseline in the Berg Balance Scale | 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 |
| Change from Baseline on the 36-item Short Form Survey | 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 |
| Change from Admission to Study on the modified Japanese Orthopaedic Association Scale | 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 |
| Change from Baseline in Motor-Evoked Potentials | 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 |
| Change from Baseline in Hoffman Reflexes | 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. |
Countries
Canada
Outcome results
None listed