NCT07636135

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

May 27, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

physical therapypost-operative rehabilitationwalkingdegenerative cervical myelopathyspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (7)

  • Change from Baseline in the Six Minute Walk Test

    Baseline and End Rehabilitation (8 weeks following Baseline)

  • Change from Baseline in the Timed Up and Go

    Baseline and End Rehabilitation (8 weeks following Baseline)

  • Change from Baseline in the Berg Balance Scale

    Baseline and End Rehabilitation (8 weeks following Baseline)

  • Change from Baseline on the 36-item Short Form Survey

    Baseline and End Rehabilitation (8 weeks following Baseline)

  • Change from Admission to Study on the modified Japanese Orthopaedic Association Scale

    Study Admission and End of Study (12 weeks)

  • +2 more secondary outcomes

Other Outcomes (4)

  • Feasibility (Participant Recruitment and Retention)

    From Study Admission to the End of Study (12 weeks)

  • Acceptability

    Immediately following rehabilitation (Week 8 for Intervention Group, Week 12 for Usual Care Control)

  • Safety (Adverse Events)

    From Study Admission to the End of Study (12 weeks)

  • +1 more other outcomes

Study Arms (2)

Usual Care Rehabilitation

ACTIVE COMPARATOR

Participants will begin post-operative rehabilitation 6 weeks following their cervical spine surgery

Behavioral: Physical Therapy

Early Rehabilitation

EXPERIMENTAL

Participants will begin post-operative rehabilitation 2 weeks following their cervical spine surgery

Behavioral: Physical Therapy

Interventions

Active, task-specific physical therapy to enhance balance, walking, and strength

Early RehabilitationUsual Care Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • discharge from acute care facility \> 2 weeks post-operative
  • intra-operative or early post-operative complication delaying discharge or precluding participation in early rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 9, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share