Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2028-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.

The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Introduction of Sophrology and Art Therapy in Hand and Upper Limb Surgery at Lyon University Hospital

NCT06918522

Hand and Upper Limb Trauma

RECRUITING

An App-based Versus a Web-based Self-management Intervention or Usual Care in People With Low Back and/or Neck Pain on a Waiting List for Hospital-based Outpatient Rehabilitation

NCT04463043

Back Pain Neck Pain

COMPLETED NA

Elbow Extension Restoration Surgery in People With Tetraplegia: Evolution of the Muscular Co-activations of the Upper Limb During the Post-operative Rehabilitation

NCT03513783

Tetraplegia

TERMINATED NA

Effect of a Case Manager to Assist the Rehabilitation for Lumbar Spinal Fusion Patients. A Randomised Controlled Trial.

NCT03433443

Rehabilitation Spinal Fusion Case Managers

COMPLETED NA

Accuracy of AuReha for Measuring Upper Limb Movements Compared to "Usual Care"

NCT07074483

Healthy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.

The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).

The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.

Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spondylolisthesis, Lumbar Region

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Self rehabilitation at home

Group Type EXPERIMENTAL

Self rehabilitation at home

Intervention Type OTHER

6 week program of exercise at home of gradual intensity and duration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self rehabilitation at home

6 week program of exercise at home of gradual intensity and duration

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
* Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
* Return home possible after surgery
* After signing consent during pre-operative visit with the surgeon

* People under 18 years-old
* Pregnant or breast-feeding women
* Psychiatric and/or neurodegenerative comorbidity
* Motor deficiency of the limbs before and/or after surgery
* Iliac extension of arthrodesis
* Any postoperative complication lengthening stay at hospital
* Medical contraindication for early rehabilitation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No