Gait Analysis and Degenerative Spine

Spinal Disease Clinical Trial

Official title:

Gait Analysis and Degenerative Spine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335095
• Other study ID #: a319
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Universidade Nova de Lisboa
• Contact: Nuno A.R. Cristino
• Email: nuno.cristino.ext[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:

• What are the biomechanical variables affected by the disease

• How they evolve with disease progression and treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2026
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 50 and 85 years

• Diagnosis of spinal disease by clinical and imagiological criteria

• More than 3 months duration of disease

• Ability to give consent

• Fluent portuguese speaker

Exclusion Criteria:

• Previous spine surgery

• Spinal instability

• Neurological disease that might interfere with walking

• Known orthopedic conditions that causes significant gait impairment

• Dementia or development disorder with cognitive impairment

• Inability to give consent

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases

Intervention

Other:
• Kinematic sensors
Comparative analysis of kinematic data acquired in supervised and unsupervised environment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in gait parameter - speed (m/s) - at 3 months	The change will be defined by a 10% increase in speed (meters/second) at 3 months from baseline assessment.	3 months
Primary	Change from baseline in gait parameter - speed (m/s) - at 6 months	The change will be defined by a 10% increase in speed (meters/second) at 6 months from baseline assessment.	6 months
Primary	Change from baseline in gait parameter - speed (m/s) - at 12 months	The change will be defined by a 10% increase in speed (meters/second) at 12 months from baseline assessment.	12 months
Primary	Change from baseline in gait parameter - step length (m) - at 3 months	The change will be defined by a 10% increase in step length (meters) at 3 months from baseline assessment.	3 months
Primary	Change from baseline in gait parameter - step length (m) - at 6 months	The change will be defined by a 10% increase in step length (meters) at 6 months from baseline assessment.	6 months
Primary	Change from baseline in gait parameter - step length (m) - at 12 months	The change will be defined by a 10% increase in step length (meters) at 12 months from baseline assessment.	12 months
Primary	Change from baseline in gait parameter - step width (m) - at 3 months	The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment.	3 months
Primary	Change from baseline in gait parameter - step width (m) - at 6 months	The change will be defined by a 10% decrease in step width (meters) at 6 months from baseline assessment.	6 months
Primary	Change from baseline in gait parameter - step width (m) - at 12 months	The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment.	12 months
Secondary	Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months	The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =2 point in NRPS (range: 0 - 10 points).	3 months
Secondary	Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months	The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =2 point in NRPS (range: 0 - 10 points).	6 months
Secondary	Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months	The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =2 point in NRPS (range: 0 - 10 points).	12 months
Secondary	Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months	The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =27% in ODI (range: 0-50 and higher scores are indicative of more disability).	3 months
Secondary	Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months	The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =27% in ODI (range: 0-50 and higher scores are indicative of more disability).	6 months
Secondary	Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months	The change will be defined on the Minimal Clinically Important Difference in treatment response defined as a decrease of =27% in ODI (range: 0-50 and higher scores are indicative of more disability).	12 months
Secondary	Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months	Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months	3 months
Secondary	Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months	Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months	6 months
Secondary	Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months	Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months	12 months
Secondary	Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months	In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.	3 months
Secondary	Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months	In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.	6 months
Secondary	Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months	In the core COMI-back, 1 question consists of 2 numerical rating scales to be answered from 0 to 10 and 5 questions to be answered by selecting 1 of 5 response options. The average of the 2 disability scores forms the disability dimension subscore. A total COMI score is determined by averaging the 5 dimension scores.	12 months