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Testing a wearable back support device along with physiotherapy to reduce back pain and improve daily work in farmers.

Development, Validation and Testing of an Agriculture Support Exoskeleton in Adjunct to Conventional Physiotherapy for Farm Labourers with Chronic Low Back Pain - NA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097725
Enrollment
24
Registered
2025-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system

Interventions

Intervention1: Agriculture Support Exoskeleton and Conventional Physiotherapy: An agriculture support exoskeleton will be designed, developed and lab-tested, followed by pilot testing to assess its i

Sponsors

Datta Meghe Institute of Higher Education and Research
Lead Sponsor
Visvesvaraya National Institute of Technology VNIT
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Farm labourers, age 25 49 years, with chronic LBP, more than 3 months on at least half the days in the past 6 months and pain felt between T12 and the gluteal fold. 2. Actively engaged in agricultural work for more than or equal to 7 hours/day. 3. Farm labourers with over more than or equal to 5 years of farming experience. 4. Willing to participate and provide informed consent 5. Working as a farm labourer during the harvesting period, Feb-March. 6. Back pain with a pain intensity rating of moderate pain with VAS 3 to 7. 7. Sacroiliac Joint dysfunction is diagnosed when at least three out of the five provocative maneuvers are positive. Of the three positive tests, either the thigh thrust or compression test should be positive. Presence of 1 or more of the following by a. Low back pain that worsens with sustained end-range movements or positions, b. Lumbar hypermobility with segmental motion assessment, c. Mobility deficits of the thorax and lumbo-pelvic/hip regions, d. Diminished trunk or pelvic-region muscle strength and endurance, e. Movement coordination impairments while performing community/work-related recreational or occupational activities.

Exclusion criteria

Exclusion criteria: 1. History of lumbar surgery in the past 12 months or scheduled for major surgery in the next 12 months, presence of radiating lower back pain, fractures, neurological disorders or spine exercise training in the 3 months before the onset of the study. 2. Uncontrolled mental health condition that would impede participation and with contraindications to physical activity. 3. Presence of inflammatory arthritis, malignancies, pregnancy or gave birth in the past 6 months. 4. Severe musculoskeletal deformities or other contraindications to Exoskeleton device use. 5. Agricultural workers working as Office employees, Truck drivers, Recent migrants, Landlords who are not working in the field, and Farmers not involved in agriculture for the past year and are involved in some other work. 6. Under medications like anticoagulants, steroids, etc. 7. Positive SLR with neural tension and slump test

Design outcomes

Primary

MeasureTime frame
Pain intensity by Quadruple VAS, Work Productivity QuestionnaireTimepoint: Assessment will be done at 1. Baseline, pre-intervention 2. Post-intervention, 6 weeks 3. Follow-up, 3 months 4. Long-term evaluation, 6 months

Secondary

MeasureTime frame
1. Roland Morris disability questionnaire 2. Revised Oswestry Disability Index 3. Short Form-12Timepoint: Assessment will be done at 1. Baseline, pre-intervention 2. Post-intervention, 6 weeks 3. Follow-up, 3 months 4. Long-term evaluation, 6 months;Timepoint:

Countries

India

Contacts

Public ContactIrshad Qureshi

Datta Meghe Institute of Higher Education and Research

irshadphysio@rediffmail.com9406010010

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026