Physical Therapy
BehavioralActive, task-specific physical therapy to enhance balance, walking, and strength
NCT Number: NCT07636135
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active, task-specific physical therapy to enhance balance, walking, and strength
Time frame: Baseline and End Rehabilitation (8 weeks following Baseline)
Time to walk ten metres; lower times indicate faster walking speed
Time frame: Baseline and End Rehabilitation (8 weeks following Baseline)
Distance walked in six minutes; longer distances indicate greater walking endurance
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
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
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
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
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
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.
Time frame: From Study Admission to the End of Study (12 weeks)
The recruitment and drop out rates will be recorded
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
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
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.
University of Alberta
Other
Feasibility of Early Post-operative Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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