Timing of Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy

NCT07636135 — Not applicable, Recruiting, 20 participants, University of Alberta

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Feasibility of Early Post-operative Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy

RegistryNCT07636135
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment20 (Estimated)
SponsorUniversity of Alberta (Other); collaborators: Alberta Spine Foundation
ConditionsCervical Myelopathy
InterventionsPhysical Therapy (Behavioral)
Datesstart 2026-07-01, primary completion 2027-10-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-06-09, last updated 2026-08-07
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Cervical Myelopathy All trials of Physical Therapy

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Usual Care RehabilitationActive comparatorBehavioral: Physical TherapyParticipants will begin post-operative rehabilitation 6 weeks following their cervical spine surgery
Early RehabilitationExperimentalBehavioral: Physical TherapyParticipants will begin post-operative rehabilitation 2 weeks following their cervical spine surgery
  • Physical Therapy (Behavioral): Active, task-specific physical therapy to enhance balance, walking, and strength

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

Other outcomes

  • Feasibility (Participant Recruitment and Retention) [From Study Admission to the End of Study (12 weeks)]: The recruitment and drop out rates will be recorded
  • Acceptability [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
  • Safety (Adverse Events) [From Study Admission to the End of Study (12 weeks)]: Details and timing of any adverse events will be documented for all participants
  • Change from Baseline in Daily Activity [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
University of AlbertaEdmonton, AlbertaCanadaRecruiting