The effect of a prototype feedback and passive spinal support device on spinal loading during load handling tasks in healthy subjects and low back pain patients.

The effect of a prototype feedback and passive spinal support device on spinal loading during load handling tasks in healthy subjects and low back pain patients. - The effect of feedback and spinal support on spinal loading.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47119

Enrollment

Registered

2016-06-14

Start date

2016-12-06

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low back pain

Interventions

see study design

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy Worker - No previous history of LBP in the last 12 months - Owestry Disability Index 20 and

Exclusion criteria

Exclusion criteria: Healthy worker * - Motor deficits and sensorimotor deficits (lower limb immobility, posture, gait, upper limbs) * - Specific radiographic abnormalities (severe disc space narrowing, spondylolysis, spondylolisthesis, scoliosis, etc.). * - Previous back surgery * - Thoracic or cervical pain * - Pain in the hip region * - Neurological disorders * - LBP in the last 2 years that did require them to seek medical attention or to change their activities;Workers with recurrent low back pain * - Motor deficits and sensorimotor deficits (lower limb immobility, posture, gait, upper limbs) * - Specific radiographic abnormalities (severe disc space narrowing, spondylolysis, spondylolisthesis, scoliosis, etc.). * - Previous back surgery * - Thoracic or cervical pain * - Pain in the hip region * - Neurological disorders

Design outcomes

Primary

Measure	Time frame
In part I and II, our main goal is to investigate if our assistive device is effective in reducing mechanical back loads, defined in terms of: * Peak and cumulative L5S1 compression force * Lumbar angular accelerations (uncontrolled spine motion) * Lumbar angles (spine flexion and asymmetrical spine motion) * Co-contraction In part III our main goal is to analyze the feasibility and satisfaction to use the assistive device in the working environment, defined in terms of: * System Usability Scale (SUS) score of each participant * Patients Global Impression of Change (PGIC) score Clinicians Global Impression of Change (CGIC) score * Individual classification code based on the ICF- framework	—

Measure

Time frame

In part I and II, our main goal is to investigate if our assistive device is effective in reducing mechanical back loads, defined in terms of: * Peak and cumulative L5S1 compression force * Lumbar angular accelerations (uncontrolled spine motion) * Lumbar angles (spine flexion and asymmetrical spine motion) * Co-contraction In part III our main goal is to analyze the feasibility and satisfaction to use the assistive device in the working environment, defined in terms of: * System Usability Scale (SUS) score of each participant * Patient*s Global Impression of Change (PGIC) score * Clinicians Global Impression of Change (CGIC) score * Individual classification code based on the ICF- framework

—

Secondary

Measure	Time frame
In parts I and II, our secondary goals are to investigate the effect of our assistive device on the work performance in terms of: * Effort - Heart rate - Perceived effort * Productivity - Time to complete the task cycle * Discomfort - Local Perceived Discomfort Scale and to investigate the effect on performance of daily activities in terms of: * Self-Paced Walk Test (SPWT) - Walking speed * Stair Climb Test (SCT) - Time * Six-Minute Walk Test (6MWT) - Distance * Chair Stand Test (CST) - Time * Timed Up and Go (TUG) - Time In part III, our secondary goal is to analyze the effect on fear of movement in terms of: * Score of Tampa Scale Kinesiophobia (TSK)	—

Measure

Time frame

In parts I and II, our secondary goals are to investigate the effect of our assistive device on the work performance in terms of: * Effort - Heart rate - Perceived effort * Productivity - Time to complete the task cycle * Discomfort - Local Perceived Discomfort Scale and to investigate the effect on performance of daily activities in terms of: * Self-Paced Walk Test (SPWT) - Walking speed * Stair Climb Test (SCT) - Time * Six-Minute Walk Test (6MWT) - Distance * Chair Stand Test (CST) - Time * Timed Up and Go (TUG) - Time In part III, our secondary goal is to analyze the effect on fear of movement in terms of: * Score of Tampa Scale Kinesiophobia (TSK)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)