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A study to develop and test a sensor-based device for measuring knee spasticity in people who have had a stroke

Development and Validation of a Sensor Based Device for Objective Assessment of Spasticity in Knee Flexors and Extensors in Stroke Survivors with Hemiplegia - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/110024
Enrollment
104
Registered
2026-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: G811- Spastic hemiplegia

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Aparna Anil Bachkaniwala
Lead Sponsor
SPB Physiotherapy College
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age: Adults aged 18 years and above. 2.Individuals diagnosed with stroke, exhibiting clinical signs of spasticity in knee flexors or extensors. 3.Able to understand and follow verbal instructions. 4.Willing and able to provide informed consent. 5.Patients who have sufficient range of motion (ROM) in the knee joint to allow passive movement.

Exclusion criteria

Exclusion criteria: 1.Musculoskeletal problems like presence of contractures, fixed deformities, severe joint instability, or recent fractures in the knee joint that would prevent safe passive movement. 2.Individuals experiencing pain during passive movement of the knee joint that could interfere with assessment or pose risk of injury. 3.Patients with skin hypersensitivity or open wounds at the site of sensor application (thigh/shank) will be excluded 4.Coexisting neurological disorders (e.g., peripheral neuropathy, Parkinson s disease) that could confound spasticity assessment. 5.Recent (within the past 3 months) treatment with botulinum toxin, phenol injections, or surgical interventions targeting spasticity in the tested limb. 6.Pregnant women (if the device or protocol poses any risk or discomfort).

Design outcomes

Primary

MeasureTime frame
Concurrent validity between sensor-derived spasticity parameters (knee angle in degrees, angular velocity in deg/s, muscle resistance/torque in Nm) and Modified Tardieu Scale (MTS) scoresTimepoint: Outcomes will be evaluated once at the time of visit of the participant.

Secondary

MeasureTime frame
Intra-rater reliability of sensor deviceTimepoint: Test-retest at 3-7 days post-baseline.

Countries

India

Contacts

Public ContactAparna Anil Bachkaniwala

SPB Physiotherapy College, Surat

appu19071987@gmail.com9033227239

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026