Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke

Seoul National University

Status: Completed

Conditions: Stroke

Treatments: Device: Robotic-assisted gait training; Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT01945515

Robot-tDCS-2013

Details and patient eligibility

About

1. Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients

2. Subjects chronic stroke patients with gait impairment

3. Methods

   • Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
   • Group 2: Robotic-assisted gait training with sham tDCS (45 min)
   • Duration of treatment: 2 weeks, 5 times a week
   • Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
• Hemiplegic patients due to unilateral lesion
• Patients in chronic stage after 6 months from stroke onset
• Patients with gait impairment (FAC <= 4)
• Adult (Age >= 18)

Exclusion criteria

• Unstable vital sign
• History of seizure or cranial operation
• unable to walk before stroke
• bilateral hemispheric lesions
• metalic implant (cardiac pacemaker, artificial cochlear, etc.)
• severe cognitive deficit, MMSE < 10
• severe aphasic patient who cannot communicate at all

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Robot + anodal tDCS

Experimental group

Description:

Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min

Treatment:

Device: tDCS

Device: Robotic-assisted gait training

Robot + sham tDCS

Sham Comparator group

Description:

Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min

Treatment:

Device: tDCS

Device: Robotic-assisted gait training