Skip to content

The effect of lower limb rehabilitation robot combined with FES on the recovery of lower limb function on patients with stroke: a fNIRS study

The effect of lower limb rehabilitation robot combined with FES on the recovery of lower limb function on patients with stroke: a fNIRS study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070417
Enrollment
Unknown
Registered
2023-04-11
Start date
2023-04-11
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

stroke

Interventions

Intervention group:Lower limb robot cooperative functional electrical stimulation training
Control group:Lower limb robot training
Observation group:With and without functional electrical stimulation

Sponsors

Changzhou De'an Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Experiment 1: (1) The patient met the diagnostic criteria for stroke determined by the Fourth National Conference on Cerebrovascular Diseases, and was confirmed by CT or MRI; (2) First, unilateral onset and stable disease; (3) Unilateral limb paralysis; (4) Aged 30-80 years; (5) The duration of the disease was less than 3 months; (6) FAC=20; (8) Family members and patients sign informed consent. 2. Experiment 2: (1) The patient met the diagnostic criteria for stroke determined by the Fourth National Conference on Cerebrovascular Diseases, and was confirmed by CT or MRI; (2) First, unilateral onset and stable disease; (3) Unilateral limb paralysis; (4) Aged 30-80 years; (5) The duration of the disease was less than 6 months; (6) FAC>=3, and can complete 10m walking under supervision; (7) Clear consciousness and cooperation, good cognition, MMSE>=20; (8) Family members and patients sign informed consent. 3. Experiment 3: (1) The patient met the diagnostic criteria for stroke determined by the Fourth National Conference on Cerebrovascular Diseases, and was confirmed by CT or MRI; (2) First, unilateral onset and stable disease; (3) Unilateral limb paralysis; (4) Aged 30-80 years; (5) The duration of the disease was less than 1 year; (6) Brunnstrom III-V stage of hemiplegic lower extremity; (7) Clear consciousness and cooperation, good cognition, MMSE>=17; (8) Family members and patients sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Experiment 1 and Experiment 2: (1) Infratentorial stroke; (2) Lower limb deformity or joint contracture, injury, lower limb movement restriction, pain; (3) Lower limb muscle tone improved ashworth>= grade 2; (4) Patients with cognitive and communication disorders cannot cooperate with treatment; (5) Patients with severe complications after stroke, such as serious heart disease, serious infection, and severe diabetes, are not suitable for this study; (6) Patients with hemiplegic side leg anaesthesia, skin injury, sensory allergy and irritation area intolerance. 2. Experiment 3: (1) Patients with progressive stroke or malignant progressive hypertension, serious visceral system diseases, malignant tumors, etc.; (2) Previous history of organic brain diseases, mental disorders, epilepsy; (3) Treat local skin injury, inflammation or hyperalgesia in stimulated areas; (4) Improved Ashworth score of the affected lower extremity >= grade 3; (5) Complicated diseases that seriously affect sensation and movement of lower limbs, such as rheumatoid arthritis, lumbar disc herniation, lower limb trauma, severe skin damage, fracture and peripheral neuropathy.

Design outcomes

Primary

MeasureTime frame
Functional near infrared spectroscopy;Fugl-Meyer lower extremity function assessment;

Secondary

MeasureTime frame
Berg balance scale;Modified Barthel index;Functional independence measurement (walking ability component);Mini-mental state examination;

Countries

China

Contacts

Public ContactXu Sheng; Wang Tong

Changzhou De'an Hospital; The People's Hospital of Jiangsu Province

wangtong60621@163.com+86 13775054061;+86 15358166010

Outcome results

None listed

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