Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients

Stroke Clinical Trial

— PLEASURE  

Official title:

Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for the Lower Extremities in Chronic Stroke Patients With Hemiplegia: A Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897752
• Other study ID #: TRIORTHO1523
• Secondary ID: UMIN-CTR
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: April 17, 2018
• Start date: March 23, 2016
• Est. completion date: December 7, 2017

Study information

• Verified date: April 2018
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE:

The previous study resulted that the gait training using Functional Electrical Stimulation (FES) improved the ankle joint function and the walking ability for the chronic stroke patients with foot drop.

In addition, the further exploratory study in multicenter obtained the result that the training with WA were especially good adaptation to the patients who have slight paralysis and can walk independently.

PURPOSE:

This multicenter prospective trial is studying to reveal whether the gait training with the WalkAide[R](WA) for chronic stroke patients who can walk independently is superior to gait training with a physical therapist.

Description:

OBJECTIVE:

To reveal whether gait training with the WA for chronic stroke patients who can walk independently (Functional Ambulation Classification [FAC] 5 or 6) is superior to gait training with a physical therapist.

OUTLINE:

This is a multicenter study. Patients continue gait training with WA or without WA for 4 weeks. The effect of rehabilitation is evaluated by 6 Minute Walk Test without device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1)First-ever hemiplegic patients 4 months after the stroke onset

• 2)Patients whose the lower extremity paralysis is estimated to be stage IV, V or VI according to the Brunnstrom stage

• 3)Patients whose spasticity of the plantar flexor muscle is estimated at 2 or less according to the Modified Ashworth Scale

• 4)Patients whose ankle dorsiflexion range of motion is 0 degree or more

• 5)Patients whose gait performance is estimated to be 5 or 6 according to the FAC

• 6)Patients who can understand the purpose and instructions of this study and complete the training

• 7)Patients who agree to participate in this study and provide their written informed consent

Exclusion Criteria:

• 1)Patients whose ankle dorsiflexion is not induced by the WA due to peripheral neuropathy

• 2)Patients who are contraindicated for the WA (e.g., patients with a metallic implant or implantable medical electrical equipment such as a cardiac pacemaker, and patients with a previous or suspected history of seizure)

• 3)Patients who underwent Botox treatment in the lower extremities within 3 months of this study registry

• 4)Patients who have nervous system (excluding stroke), cardio-respiratory system, or musculoskeletal system disorders, which may affect gait and training

• 5)Patients who had fallen down within a week prior to the registry and are regarded to be at a high risk of falling down by an attending physician

• 6)Patients whose impairment severities changed between the prior and initial assessments

• Definition of an alteration

1. Brunnstrom stage for the lower extremity: Confirm whether the stages of the prior and initial assessments are the same value. If these stages are different, this is considered to be an alteration, and the patient with this alteration should be excluded from the study.

2. Lower extremity subscale of the Fugl-Meyer Assessment: Confirm whether the change in the score between the prior and initial assessments is 5 or less. If the change is 6 or more, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study.

3. Functional Ambulation Classification: Confirm whether the categories of the prior and initial assessments are the same value. If these categories are different, then this is considered to be an alteration, and the patient with this alteration should be excluded from the study.

• 7) Patients who are regarded to be ineligible for this study by the principal investigator or co-investigators

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• gait training with WA
Thirty seven units (1 unit=20 minutes) of gait training with WA by a physical therapist for the WA group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.

Other:
• usual gait training
Thirty seven units of usual gait training by a physical therapist for the UT group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.

Locations

Country	Name	City	State
Japan	Beppu Rehabilitation Center	Beppu-city	Oita-prefecture
Japan	Fukuoka Mirai Hospital	Fukuoka-city	Fukuoka-prefecture
Japan	Hakujuji Hospital	Fukuoka-city	Fukuoka-prefecture
Japan	Nagao Hospital	Fukuoka-city	Fukuoka-prefecture
Japan	Ginowan Memorial Hospital	Ginowan-city	Okinawa-prefecture
Japan	Hospital of the University of Occupational and Environmental Health, Japan	Kitakyusyu-city	Fukuoka-prefecture
Japan	Kitakyushu Abeyamakouen Hospital	Kitakyusyu-city	Fukuoka-prefecture
Japan	Kitakyushu Yahata Higashi Hospital	Kitakyusyu-city	Fukuoka-prefecture
Japan	Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization	Kitakyusyu-city	Fukuoka-prefecture
Japan	Shin-Oji Hospital	Kitakyusyu-city	Fukuoka-prefecture
Japan	Tobata Rehabilitation Hospital	Kitakyusyu-city	Fukuoka-prefecture
Japan	Tochiku Hospital	Kitakyusyu-city	Fukuoka-prefecture
Japan	Yoshino Hospital	Kitakyusyu-city	Fukuoka-prefecture
Japan	Hyogo Prefectural Rehabilitation Central Hospital	Kobe-city	Hyogo-prefecture
Japan	Yoshida Hospital, Cerebrovascular Research Institute	Kobe-city	Hyogo-prefecture
Japan	Saitama Misato Sogo Rehabilitation Hospital	Misato-city	Saitama-prefecture
Japan	Nichinan Municipal Chubu Hospital	Nichinan-city	Miyazaki-prefecture
Japan	Nagasakikita Hospital	Nishisonogi-gun	Nagasaki-prefecture
Japan	Chuzan Hospital	Okinawa-city	Okinawa-prefecture
Japan	Sapporo Shiroishi Memorial Hospital	Sapporo-city	Hokkaido-prefecture
Japan	Tokeidai Memorial Hospital	Sapporo-city	Hokkaido-prefecture
Japan	Nanbu-Tokushukai Hospital	Shimajiri-gun	Okinawa-prefecture
Japan	Showa Hospital	Shimonoseki-city	Yamaguchi-prefecture
Japan	Yamaga Onsen Rehabilitation Hospital	Yamaga-city	Kumamoto-prefecture

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Moji Medical Center, Kyusyu Rosai Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement of QOL	Exploratory outcome for improvement of QOL	4weeks
Primary	6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)	An evaluation of the effectiveness of WA-assisted gait training using the 6MWT without any device before and after each intervention in the WA-assisted training group (WA group) and usual training group (UT group).	4weeks
Secondary	Lower extremity subscale of the Fugl-Meyer Assessment	An evaluation of the severity of lower extremity using the total score of lower extremity subscale of the Fugl-Meyer Assessment (perfect score: 34 points).	4weeks
Secondary	Muscle strength of the ankle dorsiflexor muscle	An evaluation of the value(Newton/kg) using the ankle back flexor force of three times measured on average, divided by the weight value.	4weeks
Secondary	Ankle dorsiflexion range of motion	An evaluation of range of motion (ROM) as the angle of the ankle succumbed back from the knee joint flexed position in the chair seat position (5 ° increments).	4weeks
Secondary	Modified Ashworth Scale for the plantar flexor muscle	An evaluation of Modified Ashworth Scale (MAS) as the degree of muscle tone six levels ( 0 , 1 , 1+ , 2 , 3 , 4 ) .; The extent of MAS number indicating the muscle tone degree.	4weeks
Secondary	10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).	An evaluation of the effectiveness of WA-assisted gait training using the 10MWT without any device before and after each intervention in the WA and UT groups.	4weeks
Secondary	Stroke Impact Scale	An evaluation of summation score of the total score and physical domain (sixth domain) score.	4weeks
Secondary	Adverse event assessment	A frequency counting of the adverse events. LLT code will be assigned to the reported adverse event using the MedDRA dictionary.; The origin date of the term until adverse events define the start date of the protocol treatment.	4weeks