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Functional Electrical Simulator for Hemiplegics

Feasibility Study of a Functional Electrical Stimulation (FES) in Chronic Stroke Patients (Hemiplegics) - DDH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/09/003019
Enrollment
90
Registered
2012-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Hemiplegia

Interventions

Intervention1: Applying Functional Electrical Stimulation (FES) using indigenous low cost NIOH-IITKGP (version 1.0)FES device. This therapy will be given to stoke patients by trained physiotherapist.:

Sponsors

Ministry of Social Justice and Empowerment Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - An individual with foot drop following stroke affecting one lower limb(Unilateral lower extremity hemiplegia) - visible ankle dorsi-flexion when FES is given - Motivated and willing to participate in study - Full voluntary dorsiflexion of the contralateral ankle - Patients to whom caregiver assistance is available - No significant skeletal abnormality - Have inadequate dorsiflexion/limb clearance or unable to achieve normal heel strike on ambulation without AFO - Medically stable for 3 months following the last episode of stroke - Adequate cognitive and communication function to give informed consent, understand the training instructions and to give feedback if asked - Able to ambulate 10 meters continuously with minimal assistance without the use of an Ankle-Foot Orthosis (AFO).

Exclusion criteria

Exclusion criteria: - Neuronal disorders other than stroke such as Parkinsonâ??s, spinal cord injury or Multiple Sclerosis - Severe cardiac disease such as myocardial infraction, congestive heart failure - Significant skin lesion or allergy to electrodes. - Severe cases of arm flexion deformity - Implanted electronic equipment, such as pacemakers and intracardiac defibrillators - Patients with leg having regional disorder, such as a fracture or dislocation - Patients with Diabetes mellitus - Severely impaired cognition and communication - History of peroneal nerve injury - seizure - Edema of the affected lower extremity - Absent sensation of lower leg and foot - Evidence of deep venous thrombosis or thromboembolism - Pregnancy

Design outcomes

Primary

MeasureTime frame
-Walking speed [m/s] -Quantitative Gait Analysis. Parameters to be measured are Single Support, Double Support, SLS/DLS, Swing Duration, Step Duration, Cycle Duration, Pulling Acceleration, Swing Power, Ground Impact, Foot fall, Push off, Speed, Cadence, Step Length, Stride Length -Energy expenditure [kcal/m] -sEMG changes of tibialis anterior in time-frequency domain -Active ROM of Ankle. -EEG changes in time-frequency domain.Timepoint: For above all measurement at : Baseline (Pre-treatment ), after 12 weeks of FES intervention and at the end of intervention (i.e. after 24 months)

Secondary

MeasureTime frame
-Fugl-Meyer Lower Extremity Motor Assessment -Modified ash-worth scale for lower limb -Skin conductance change at stimulation site [micro-Siemens] -Blood volume pulse (BVP) measurement using photo-plethysmography -Reusable electrode condition during intervention. -Questionnaire about impression of the interventions, complaints, ability to dorsiflex ankle and any effect on their walking. A questionnaire about confidence and independence while walking with FES deviceTimepoint: For above all measurement at : Baseline (Pre-treatment ), after 12 weeks of FES intervention and at the end of intervention (i.e. after 24 months)

Countries

India

Contacts

Public ContactLenka P K

School of Medical Science and Technology, Indian Institute of Technology (IIT)â?? Kharagpur

shendkar.shekhar@gmail.com91-3222-281222

Outcome results

None listed

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