Occupational Therapy for Spinal Cord Compression

Overseen By Sarah Detombe, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Other neurological disorder, Systemic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if occupational therapy rehabilitation after spine surgery can enhance brain flexibility and improve recovery from spinal cord compression. Researchers will compare patients receiving therapy to those who do not, assessing the impact on brain function and recovery. The trial is suitable for right-handed individuals who have experienced worsening neurological issues for less than 24 months and can undergo MRI scans. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research and potentially improve recovery outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this rehabilitation therapy is safe for spinal cord compression patients?

Research has shown that occupational therapy for spinal cord injuries is generally safe and well-tolerated. Studies indicate that most patients benefit from these therapy programs, with 91% of adults achieving or surpassing their personal goals during rehabilitation. This therapy not only aids recovery but is also manageable for patients. Reports of harmful side effects are insignificant, making it a promising option for those seeking to improve nerve function and overall recovery after spinal surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about occupational therapy rehabilitation for spinal cord compression because it focuses on improving a patient's ability to perform daily activities, which is a different approach compared to the standard treatments such as surgery or medication. This therapy emphasizes personalized, hands-on techniques that help patients regain functionality and independence, addressing the practical challenges they face in everyday life. By enhancing fine motor skills and adapting tasks to individual needs, occupational therapy offers a holistic, non-invasive option that could complement or even reduce the need for more invasive procedures.

What evidence suggests that occupational therapy rehabilitation is effective for spinal cord compression?

Research has shown that occupational therapy can significantly benefit people with spinal cord injuries. In this trial, participants will divide into two groups: one receiving rehabilitation and the other not. Studies have found that thorough rehabilitation can improve patients' abilities, with an average increase of 35.7 points on the SCIM test, which measures daily activity performance. Another study found that rehabilitation programs help patients regain function and independence, highlighting the importance of learning daily living skills. Through occupational therapy, patients may also acquire essential skills to manage environmental challenges, leading to better recovery. Overall, these findings suggest that rehabilitation, including occupational therapy, can greatly aid recovery from spinal cord injuries. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for right-handed individuals with progressive neurological deficits lasting less than 24 months, who are eligible for MRI scans. It's designed to help those recovering from non-traumatic spinal cord injuries like spondylosis and cervical myelopathy.

Inclusion Criteria

My neurological symptoms have worsened in the last 2 years.

Right-handed

Eligible for MRI scanning

Exclusion Criteria

I am not fluent in English.

Being claustrophobic

I have a condition that affects my nervous system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative evaluation including advanced imaging techniques

1-2 weeks

Surgery

Participants undergo spine surgery as part of the clinical care platform

1 week

Rehabilitation

Participants receive rehabilitative therapy to increase brain plasticity and recovery of neurological function

6 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

6 months

Follow-ups at 4 weeks, 6 weeks, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Occupational therapy rehabilitation

Trial Overview The study tests how occupational therapy rehabilitation after spine surgery can improve brain plasticity and recovery of neurological function in patients with spinal cord injury, using advanced imaging techniques to track progress.

How Is the Trial Designed?

Group I: Rehabilitation Experimental Treatment 1 Intervention

Group II: No rehabilitation Active Control 1 Intervention

Occupational therapy rehabilitation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Occupational therapy for:

• Spinal cord injury rehabilitation
• Neurological function recovery

Approved in European Union as Occupational therapy for:

• Spinal cord injury rehabilitation
• Neurological function recovery

Approved in Canada as Occupational therapy for:

• Spinal cord injury rehabilitation
• Neurological function recovery

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

Patients with spinal cord injury (SCI) received an average of 52 hours of occupational therapy (OT) during rehabilitation, with significant variations in time spent on different activities based on the type of neurological injury.

The most time-consuming OT activities included strengthening/endurance exercises, activities of daily living (ADLs), and range of motion/stretching, with 77% of therapy occurring in individual sessions, highlighting the importance of personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SCIRehab project: treatment time spent in SCI rehabilitation. Occupational therapy treatment time during inpatient spinal cord injury rehabilitation. Foy, T., Perritt, G., Thimmaiah, D., et al.[2023]

Occupational Therapy for spinal cord injured patients has evolved from focusing solely on manual activities to emphasizing the attainment of independence, highlighting the importance of functional levels in patient care.

Creative activities and computer-based technology have been integrated into OT regimens, demonstrating that these approaches can support patients in achieving greater independence and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Between creativity and functional use--development and determination of the status of ergotherapy in rehabilitation of the spinal cord injured patient]. Knauss, R.[2012]

The occupational therapy program for patients with acute spinal cord injuries was designed to provide immediate rehabilitation in the acute care setting, emphasizing early intervention.

Developed collaboratively by experts from Northwestern Memorial Hospital and the Rehabilitation Institute of Chicago, the program includes comprehensive guidelines for evaluation, treatment, orthotic selection, and psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy management of the acute spinal cord-injured patient. Sargant, C., Braun, MA.[2019]

In a study of 29 occupational therapy students, it was found that patient falls are the most frequently unreported safety incidents, with 47.1% of students never reporting them, despite falls being the most commonly reported issue overall (41.1%).

The study highlights a significant under-reporting of safety incidents, particularly in documentation and equipment-related issues, indicating a need for improved reporting practices and measures to enhance patient safety during academic practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient safety in the training practices of an undergraduate program in Occupational Therapy]. Peñas-Felizzola, OL., Parra-Esquivel, EI., Gómez-Galindo, AM.[2022]

A study involving 72 patients with complete cervical tetraplegia showed that occupational therapy significantly improved their ability to perform daily activities, with notable increases in self-care scores after six weeks of therapy.

The therapy sessions, conducted by a trained occupational therapist, resulted in significant improvements in specific tasks such as feeding, bathing, dressing, and grooming, indicating the effectiveness of OT in enhancing independence for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of occupational therapy in improving activities of daily living performance in complete cervical tetraplegic patients; A quasi experimental study. Arsh, A., Anwar, Z., Zeb, A., et al.[2023]

In a study of 136 patients with spinal cord injuries, those with incomplete injuries (ASIA-B, ASIA-C) achieved higher levels of independence during early rehabilitation compared to those with complete injuries (ASIA-A), with 45.9% of incomplete cases reaching expected independence levels.

The effectiveness of occupational therapy was significantly influenced by the level of spinal cord injury, as patients with cervical injuries showed a higher likelihood of achieving their rehabilitation goals (33.3-100% success) compared to those with thoracic-lumbar injuries, where no patients reached expected independence levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy for patients with spinal cord injury in early rehabilitation. Mingaila, S., Krisciūnas, A.[2018]

A quality assurance study was conducted to improve equipment ordering for spinal cord-injured clients, focusing on optimizing functioning while managing costs.

The study involved a follow-up survey of patients from the New England Regional Spinal Cord Injury Center, which identified issues in equipment ordering and led to a plan that enhanced accountability based on client needs and injury levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assurance in equipment ordering for the spinal cord-injured client. Smith, R.[2019]

In a study of 95 individuals with spinal cord injury (SCI) during inpatient rehabilitation, most participants reported spending significant time in sedentary leisure activities, with little to no engagement in higher intensity physical activities outside of therapy sessions.

However, there was a notable increase in physical activity measured by accelerometers from admission to discharge, particularly in individuals with tetraplegia and those who were ambulatory, indicating that patients can enhance their activity levels during their rehabilitation stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity outside of structured therapy during inpatient spinal cord injury rehabilitation. Zbogar, D., Eng, JJ., Miller, WC., et al.[2018]

Occupational therapy (OT) interventions during inpatient spinal cord injury rehabilitation significantly influence functional outcomes, particularly for specific patient subgroups, such as those with motor complete paraplegia and low tetraplegia.

For patients with motor complete paraplegia, focusing on clothing management and hygiene related to toileting was linked to better self-care scores, while for those with low tetraplegia, training in lower body dressing and wheelchair mobility was crucial for improving their functional independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of occupational therapy inpatient rehabilitation interventions and patient characteristics to outcomes following spinal cord injury: the SCIRehab project. Ozelie, R., Gassaway, J., Buchman, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4303793/

Rehabilitation of spinal cord injuries - PMC Therapeutic strategies and results of clinical studies related to the rehabilitation of patients with spinal cord injury. Ref. Therapeutic strategy, Results ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525001077

Effective and efficient rehabilitation. What works best for ... Comprehensive (sub)acute rehabilitation for persons with SCI/D is effective, with an average improvement of 35.7 SCIM points. Key factors ...

3. link.springer.com link.springer.com/article/10.1007/s10389-023-02115-9

An analysis of the effectiveness of rehabilitation protocols ... An analysis of the effectiveness of rehabilitation protocols for patients with spinal cord injury: A systematic review | Journal of Public ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0308022619879019

The effectiveness of spinal cord injury ADL inpatient ... This systematic review evaluates the effect of activities of daily living education on rehabilitation outcomes following spinal cord injury.

5. physio-pedia.com physio-pedia.com/The_Role_of_Occupational_Therapy_in_Acute_Spinal_Cord_Injury

The Role of Occupational Therapy in Acute Spinal Cord ... Active participation in their care during the acute phase of spinal cord injury will help patients build future skills in negotiating environmental barriers, ...

6. physio-pedia.com physio-pedia.com/Spinal_Cord_Injury_Outcome_Measures_Overview

Spinal Cord Injury Outcome Measures Overview This page presents the best available information on how outcome measures for spinal cord injury might be classified and selected for use.

7. pva.org pva.org/wp-content/uploads/2021/09/cpg_outcomes-following-traumatic-sci.pdf

Outcomes Following Traumatic Spinal Cord Injury Document deviations in the achievement of func- tional outcomes (with reference to the normative data in Table 6) by groups of individuals receiving.

8. shepherd.org shepherd.org/outcomes/patient-outcomes/spinal-cord-injury/

Spinal Cord Injury Outcomes 91% of adult patients reach or exceed their expected personal goals during their rehabilitation. Patients work with their therapy team to come up with goals.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04735887

The Impact of an Evidence-Informed Spinal Cord Injury ... This study argues that providing evidence-based occupational therapy patient education is vital in order to optimize rehabilitation outcomes. The planned ...