StrokePLEASURENCT02897752
Clinical Effects of Peroneal Nerve Functional Electrical Stimulation (WalkAide[R]) for Chronic Stroke Patients
A study testing gait training with WA and usual gait training in people with Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 24 sites in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- gait training with WA and usual gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 24 sitesJapan
- Study dates
- 23 Mar 2016to 7 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Definition of an alteration
- 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.
- 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.
- 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
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
Beppu Rehabilitation Center
Beppu, Oita Prefecture, 874-8611
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, 813-0017
Nagao Hospital
Fukuoka, Fukuoka, 814-0153
Hakujuji Hospital
Fukuoka, Fukuoka, 819-8511
Ginowan Memorial Hospital
Ginowan, Okinawa, 901-2211
Kitakyushu Abeyamakouen Hospital
Kitakyushu, Fukuoka, 800-0257
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
Kitakyushu, Fukuoka, 801-8502
Tobata Rehabilitation Hospital
Kitakyushu, Fukuoka, 804-0092
Kitakyushu Yahata Higashi Hospital
Kitakyushu, Fukuoka, 805-0061
Shin-Oji Hospital
Kitakyushu, Fukuoka, 806-0057
Tochiku Hospital
Kitakyushu, Fukuoka, 807-0856
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, 807-8555
Yoshino Hospital
Kitakyushu, Fukuoka, 808-0034
Hyogo Prefectural Rehabilitation Central Hospital
Kobe, Hyōgo, 651-2181
Yoshida Hospital, Cerebrovascular Research Institute
Kobe, Hyōgo, 652-0803
Saitama Misato Sogo Rehabilitation Hospital
Misato, Saitama, Saitama, 341-0034
Nichinan Municipal Chubu Hospital
Nichinan, Miyazaki, 889-3141
Nagasakikita Hospital
Nishisonogi-gun, Nagasaki, 851-2103
Chuzan Hospital
Okinawa, Okinawa, 904-2151
Sapporo Shiroishi Memorial Hospital
Sapporo, Hokkaido-prefecture, 003-0026
Tokeidai Memorial Hospital
Sapporo, Hokkaido-prefecture, 060-0031
Nanbu-Tokushukai Hospital
Shimajiri-gun, Okinawa, 901-0493
Showa Hospital
Shimonoseki, Yamaguchi, 750-0059
Yamaga Onsen Rehabilitation Hospital
Yamaga, Kumamoto, 861-0514
About this study
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
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.
Read the detailed 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.
- Conditions
- Stroke
- Being tested
- gait training with WA, usual gait training
- Keywords
- stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait training with WADevice
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.
usual gait trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| WalkAide | Experimental | Not described Receives: Device: gait training with WA |
| Usual gait Training | Active comparator | Not described Receives: Other: usual gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4weeks
Secondary outcomes (7)
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).
Measured: 4weeks
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.
Measured: 4weeks
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).
Measured: 4weeks
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.
Measured: 4weeks
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.
Measured: 4weeks
Stroke Impact Scale
An evaluation of summation score of the total score and physical domain (sixth domain) score.
Measured: 4weeks
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.
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start23 Mar 2016
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Moji Medical Center, Kyusyu Rosai Hospital
- Responsible party
- Sponsor
- Investigators
- Kenji Hachisuka, MD, Ph.D, Study chair, Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897752
- Sponsor's protocol ID
- TRIORTHO1523
- Other IDs
- UMIN-CTR
- Acronym
- PLEASURE
- Status last verified
- Apr 2018
- First submitted
- 5 Aug 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02897752
- Acronym / sponsor ID
- PLEASURE / TRIORTHO1523
- Conditions
- Stroke
- Keywords
- stroke, Rehabilitation, WalkAide (WA), Functional Electrical Stimulation (FES)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Moji Medical Center, Kyusyu Rosai Hospital
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WalkAide | Experimental | Device: gait training with WA |
| Usual gait Training | Active comparator | Other: usual gait training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait training with WAThirty 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. | Device | WalkAide |
| usual gait trainingThirty 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. | Other | Usual gait Training |
Primary outcome
6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort)
Time frame: 4weeks
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).
7 secondary outcomes
Lower extremity subscale of the Fugl-Meyer Assessment
Time frame: 4weeks
Muscle strength of the ankle dorsiflexor muscle
Time frame: 4weeks
Ankle dorsiflexion range of motion
Time frame: 4weeks
Modified Ashworth Scale for the plantar flexor muscle
Time frame: 4weeks
10 Meter Walk Test (10MWT; speed while walking a set distance of 10 m at the patient's preferred speed).
Time frame: 4weeks
Stroke Impact Scale
Time frame: 4weeks
Adverse event assessment
Time frame: 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenji Hachisuka, MD, Ph.D study chair
Moji Medical Center, Kyusyu Rosai Hospital, Japan Labour Health Welfare Organization
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait training with WA and usual gait training in people with Stroke, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 24 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6MWT; walking distance during a 6-minute walk with maximum effort) (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.