New treatment option for Spine
Official title Early Mobilization Following Elective Spine Surgery: Trial of In-bed Cycling
ClinicalTrials.gov ID: NCT07506720
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if early mobilization using an in-bed cycling device can reduce the amount of time patients spend in bed after elective spine surgery in adults. The main questions it aims to answer are: Does in-bed cycling on the day after surgery reduce the amount of time patients spend in bed over the next 24 hours?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥ 18 years old.
- Postoperative #0 following elective spinal surgery: decompression with or without fusion, or fusion.
- Patient able to walk independently before surgery (does not require assistance from another person and does not use a wheelchair).
- Patient admitted directly from the operating room to the ward.
- Hemodynamically stable:
You likely can't join if
- Non-ambulatory preoperatively.
- Body Mass Index (BMI) \> 40 kg/m².
- Acute neurological spinal trauma.
- Non-neurological musculoskeletal impairment of the lower limbs (e.g., severe osteoarthritis, hip fracture, amputation) limiting the ability to pedal...
- Uncontrolled comorbidities preventing surgery or intervention (cardiovascular, respiratory, diabetes).
- Expected hospital stay of less than 2 days after surgery.
See the full eligibility criteria
- Male or female ≥ 18 years old.
- Postoperative #0 following elective spinal surgery: decompression with or without fusion, or fusion.
- Patient able to walk independently before surgery (does not require assistance from another person and does not use a wheelchair).
- Patient admitted directly from the operating room to the ward.
- Hemodynamically stable:
- Systolic blood pressure (SBP): ≥ 90 mmHg and \< 140 mmHg
- Oxygen saturation \> 94%
- Heart rate: 50-100 bpm
- Patient approved for surgery after preoperative internal medicine evaluation.
- Patient alert and conscious.
- Valid informed consent obtained.
- Non-ambulatory preoperatively.
- Body Mass Index (BMI) \> 40 kg/m².
- Acute neurological spinal trauma.
- Non-neurological musculoskeletal impairment of the lower limbs (e.g., severe osteoarthritis, hip fracture, amputation) limiting the ability to pedal in bed.
- Uncontrolled comorbidities preventing surgery or intervention (cardiovascular, respiratory, diabetes).
- Expected hospital stay of less than 2 days after surgery.
- Surgery-related complications: acute neurological deficit, dural tear, cerebrospinal fluid (CSF) leak, residual spinal instability.
- Transfer to intensive care unit or hemodynamic instability.
- Persistent hemodynamic instability: SBP \ 200 mmHg, oxygen saturation \ 100 bpm, temperature \> 38°C.
- Capillary blood glucose outside target values: \ 7.0 mmol/L fasting or pre-meal, \ 10.0 mmol/L 2 hours post-meal.
- Patient confused, disoriented, or agitated.
- Patient already evaluated by physiotherapy for discharge planning or intensive functional rehabilitation.
- Patient in isolation.
- Patient already discharged.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.