Timing of Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy
ConditionCervical Myelopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
discharge from acute care facility > 2 weeks post-operative
intra-operative or early post-operative complication delaying discharge or precluding participation in early rehabilitation
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Therapy
BehavioralActive, task-specific physical therapy to enhance balance, walking, and strength
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Usual Care RehabilitationActive comparator 1 intervention
Group B: Early RehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Ten Metre Walk Test
Time to walk ten metres; lower times indicate faster walking speed
Time frame
Baseline and End Rehabilitation (8 weeks following Baseline)Secondary outcomes
1
Change from Baseline in the Six Minute Walk Test
Distance walked in six minutes; longer distances indicate greater walking endurance
Time frame
Baseline and End Rehabilitation (8 weeks following Baseline)2
Change from Baseline in the Timed Up and Go
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)3
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
Time frame
Baseline and End Rehabilitation (8 weeks following Baseline)4
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
Time frame
Baseline and End Rehabilitation (8 weeks following Baseline)Other outcomes
1
Feasibility (Participant Recruitment and Retention)
The recruitment and drop out rates will be recorded
Time frame
From Study Admission to the End of Study (12 weeks)2
Acceptability
Participants will describe their satisfaction with the intervention (including content and timing) through a custom survey following the intervention
Time frame
Immediately following rehabilitation (Week 8 for Intervention Group, Week 12 for Usual Care Control)3
Safety (Adverse Events)
Details and timing of any adverse events will be documented for all participants
Time frame
From Study Admission to the End of Study (12 weeks)4
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.
Time frame
Baseline and End Rehabilitation (8 weeks following Baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Alberta Spine Foundation
Collaborator
Source ClinicalTrials.gov