Pharmacological and device-based interventions for paraplegia: A ClinicalTrials.gov-based analysis

Paraplegia, resulting from spinal cord injury or neurological disease, presents significant challenges in long-term care and rehabilitation. Effective therapeutic strategies are crucial for improving mobility, reducing complications, and enhancing quality of life. To systematically analyze clinical trials registered on ClinicalTrials.gov that investigate pharmacological, device-based, and procedural interventions for individuals with paraplegia. A retrospective analysis of 84 paraplegia-related clinical trials registered on ClinicalTrials.gov was conducted on July 3, 2025. Studies were categorized by type (interventional or observational), intervention class (pharmacological, device-based, behavioral, biological, or procedural), and primary outcome focus. Emphasis was placed on interventional trials (n = 61), with descriptive analyses of sample size, enrollment range, and outcome categories. Among the 84 included studies, 61 (73%) were interventional and 23 (27%) were observational. Device-based interventions (n = 30) were the most frequently investigated and included exoskeleton-assisted walking, functional electrical stimulation, and robotic rehabilitation systems. Pharmacological interventions (n = 10) targeted spasticity, neuroprotection, and cardiovascular regulation. Behavioral interventions (n = 7) emphasized patient engagement and rehabilitation planning, while biological and procedural therapies (n = 7) focused on neurostimulation and regenerative strategies. Primary outcomes most commonly assessed mobility/function (n = 13), safety (n = 9), and cardiometabolic parameters (n = 6), with many studies reporting small sample sizes. Clinical trials in paraplegia research are increasingly centered on pharmacological and device-supported interventions aimed at enhancing motor recovery and minimizing secondary disability. While variability in sample size and outcome measures exists, this analysis highlights promising directions for optimizing long-term management of paraplegia. Greater standardization in trial design and outcome reporting will be essential for advancing therapeutic effectiveness and clinical applicability.

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Journal
Medicine
Published
2026-02-27
DOI
https://doi.org/10.1097/md.0000000000047946
Primary Topic
Spinal Cord Injury Research
Type
article
Field-Weighted Citation Impact
0.00

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article

Pharmacological and device-based interventions for paraplegia: A ClinicalTrials.gov-based analysis

Nasser M. Alorfi, Mohammed M. Aldurdunji, Safa S. Almarzoky Abuhussain, Fahad S. Alshehri et al.
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article

Pharmacological and device-based interventions for paraplegia: A ClinicalTrials.gov-based analysis

Nasser M. Alorfi, Mohammed M. Aldurdunji, Safa S. Almarzoky Abuhussain, Fahad S. Alshehri, Saad M. Wali, Beisan A. Mohammad, Nihal Abdalla Ibrahim, Ahmed M. Ashour
article en

Abstract

Paraplegia, resulting from spinal cord injury or neurological disease, presents significant challenges in long-term care and rehabilitation. Effective therapeutic strategies are crucial for improving mobility, reducing complications, and enhancing quality of life. To systematically analyze clinical trials registered on ClinicalTrials.gov that investigate pharmacological, device-based, and procedural interventions for individuals with paraplegia. A retrospective analysis of 84 paraplegia-related clinical trials registered on ClinicalTrials.gov was conducted on July 3, 2025. Studies were categorized by type (interventional or observational), intervention class (pharmacological, device-based, behavioral, biological, or procedural), and primary outcome focus. Emphasis was placed on interventional trials (n = 61), with descriptive analyses of sample size, enrollment range, and outcome categories. Among the 84 included studies, 61 (73%) were interventional and 23 (27%) were observational. Device-based interventions (n = 30) were the most frequently investigated and included exoskeleton-assisted walking, functional electrical stimulation, and robotic rehabilitation systems. Pharmacological interventions (n = 10) targeted spasticity, neuroprotection, and cardiovascular regulation. Behavioral interventions (n = 7) emphasized patient engagement and rehabilitation planning, while biological and procedural therapies (n = 7) focused on neurostimulation and regenerative strategies. Primary outcomes most commonly assessed mobility/function (n = 13), safety (n = 9), and cardiometabolic parameters (n = 6), with many studies reporting small sample sizes. Clinical trials in paraplegia research are increasingly centered on pharmacological and device-supported interventions aimed at enhancing motor recovery and minimizing secondary disability. While variability in sample size and outcome measures exists, this analysis highlights promising directions for optimizing long-term management of paraplegia. Greater standardization in trial design and outcome reporting will be essential for advancing therapeutic effectiveness and clinical applicability.

MedicineVol. 105(9)
Ajman University (AE), Umm al-Qura University (SA), King Salman Center for Disability Research (SA), Soliman Fakeeh Hospital (SA)
King Salman Center for Disability Research
Openalex Percentile: Top 42%
Spinal Cord Injury Research
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