HemiparesisGT-1-tDCSNCT01040299

Mechanized Gait Trainer Combine Transcranial Galvanic Stimulation (tDCS) in Chronic Stroke

A study testing GangTrainer and tDCS in people with Hemiparesis and Cerebrovascular Disorders, run by Universita di Verona at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hemiparesis, Cerebrovascular Disorders
What is being tested?: GangTrainer and tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteItaly
Study dates: Jul 2010to Oct 2010
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

European Stroke scale between 75-85
First time supratentorial, ischaemic or hemorrhagic stroke.
Diagnosis of ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography > 6 months after the onset of stroke.
Age < 80 years.
Ability to stand upright, supported or unsupported, for 1 minute.
Patients with ischaemic or haemorrhagic stroke.

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In-patient participating in a comprehensive rehabilitation programme.
patients written informed consent of participation in the study approved by the local ethical committee.
absence of cardiac, psychological and orthopedic conditions that might interfere with the result.

Who cannot join

Preceding epileptic fits.
an EEG suspect of elevated cortical excitability.
a sensitive scalp skin.
severe cognitive impairment.
metallic implants within the brain.
previous brain neurosurgery.
medications altering the level of cortical excitability
medications with a presumed positive or negative effect on brain plasticity.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienta Ospedaliera, SSO Rehabilitation Unit, Verona
Verona, Italy, Verona, 37134

Other trials in Italy

About this study

Official title: Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial

Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective, but nevertheless only a few patients could use their affect lower limb functionally in daily life on deambulation after robot training. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation.

Read the detailed description

Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation. The rehabilitation programme are compose 3 kinds of locomotor training interventions (experimental group, control group 1 and control group 2).

During intervention experimental group, patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital. The anodal stimulation is expected to facilitate the activity of the lower limb motor area side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation, and the control group 2 receive a total of 10 treatments with convectional physiotherapy

Conditions: Hemiparesis, Cerebrovascular Disorders
Being tested: GangTrainer and tDCS, control group1, Control group2
Keywords: GangTrainer, Gait Rehabilitation, Cerebrovascular Disorders, Robot assisted, Transcranial direct current stimulation
Medical subject headings: Paresis, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GangTrainer and tDCSDevice
The experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital.
control group1Device
Also called GangTrainerGT1
The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
Control group2Other
Also called convectional physiotherapy
The control group 2 receive a total of 10 treatments with convectional physiotherapy.

Study groups in NCT01040299
Study group	Role	What they receive
GangTrainer and tDCS	Experimental	The experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital. Receives: Device: GangTrainer and tDCS
control group1	Sham comparator	The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation. Receives: Device: control group1
control group2	Active comparator	The control group 2 receive a total of 10 treatments with convectional physiotherapy. Receives: Other: Control group2

What is being measured

The primary outcome is the main question the study is designed to answer.

Motricity Index
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

Secondary outcomes (10)

Barthel Index
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
European Stroke Scale
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Modified Ashworth Scale
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Questionary of Ambulation
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Rivermead Motor Assessment Score
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Functional Ambulation Category
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Ten Meters Walking Test
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Six Minutes Walking Test
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Spatia-temporal Gait analysis
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Motricity Index
Measured: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Oct 2010

First posted29 Dec 2009 (estimated)
Study startJul 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HemiparesisStudies 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: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01040299
Sponsor's protocol ID: GT-1-tDCS
Acronym: GT-1-tDCS
Status last verified: Mar 2012
First submitted: 28 Dec 2009
Last updated: 26 Mar 2012
Results posted: No
Data monitoring committee: Yes

Publications

Hesse S, Werner C, Schonhardt EM, Bardeleben A, Jenrich W, Kirker SG. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: a pilot study. Restor Neurol Neurosci. 2007;25(1):9-15.
PubMed 17473391
Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
PubMed 17213237
Dias D, Lains J, Pereira A, Nunes R, Caldas J, Amaral C, Pires S, Costa A, Alves P, Moreira M, Garrido N, Loureiro L. Can we improve gait skills in chronic hemiplegics? A randomised control trial with gait trainer. Eura Medicophys. 2007 Dec;43(4):499-504.
PubMed 18084173

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
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All Hemiparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combine Mechanized Gait Trainer and Transcranial Direct Current Stimulation in Chronic Stroke Patients: Randomized Control Trial
ClinicalTrials.gov ID: NCT01040299
Acronym / sponsor ID: GT-1-tDCS / GT-1-tDCS
Conditions: Hemiparesis, Cerebrovascular Disorders
Keywords: GangTrainer, Gait Rehabilitation, Cerebrovascular Disorders, Robot assisted, Transcranial direct current stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Universita di VeronaUniversity, hospital or other
Study start: Jul 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 29 Dec 2009 (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.

Detailed description

Transcranial galvanic stimulation (tDCS), seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe lower limb paresis after stroke, the GangTrainer GT1 (GT) proved to be effective. Therefore the present study intends to combine both approaches, tDCS + GT, apply at the same time every day for two weeks in order to improve the effectiveness of GangTrainer therapy in the gait rehabilitation. The rehabilitation programme are compose 3 kinds of locomotor training interventions (experimental group, control group 1 and control group 2).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
GangTrainer and tDCS	Experimental	Device: GangTrainer and tDCSThe experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital.
control group1	Sham comparator	Device: control group1The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.
control group2	Active comparator	Other: Control group2The control group 2 receive a total of 10 treatments with convectional physiotherapy.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

European Stroke scale between 75-85
First time supratentorial, ischaemic or hemorrhagic stroke.
Diagnosis of ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography > 6 months after the onset of stroke.
Age < 80 years.
Ability to stand upright, supported or unsupported, for 1 minute.

Key exclusion criteria (8 listed)

Preceding epileptic fits.
an EEG suspect of elevated cortical excitability.
a sensitive scalp skin.
severe cognitive impairment.
metallic implants within the brain.

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
GangTrainer and tDCSThe experimental group patients receive a total of 10 treatments of repetitive locomotor training with electromechanical gait device (duration 30 min) + tDCS (duration first 7 min) with the anodal electrode is place over the presumed lower limb area of the lesioned hemisphere, and the cathodal electrode is place above the controlateral orbital.	Device	GangTrainer and tDCS
control group1Also: GangTrainerGT1The control group 1 receive a total of 10 treatments with only GT (duration 30 min) with sham-stimulation.	Device	control group1
Control group2Also: convectional physiotherapyThe control group 2 receive a total of 10 treatments with convectional physiotherapy.	Other	control group2

Primary outcome

Motricity Index
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.

10 secondary outcomes

Barthel Index
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
European Stroke Scale
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Modified Ashworth Scale
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Questionary of Ambulation
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Rivermead Motor Assessment Score
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Functional Ambulation Category
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Ten Meters Walking Test
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Six Minutes Walking Test
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Spatia-temporal Gait analysis
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU
Motricity Index
Time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment, after the end (after 6 weeks) of the treatment and at 1 month FU

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 26 Mar 2012.
Background: PubMed 17473391Hesse S, Werner C, Schonhardt EM, Bardeleben A, Jenrich W, Kirker SG. Combined transcranial direct current stimulation and robot-assisted arm training in subacute stroke patients: a pilot study. Restor Neurol Neurosci. 2007;25(1):9-15.
Results publication: PubMed 17213237Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
Results publication: PubMed 18084173Dias D, Lains J, Pereira A, Nunes R, Caldas J, Amaral C, Pires S, Costa A, Alves P, Moreira M, Garrido N, Loureiro L. Can we improve gait skills in chronic hemiplegics? A randomised control trial with gait trainer. Eura Medicophys. 2007 Dec;43(4):499-504.

Related trials for Hemiparesis

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Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
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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.

Nicola Smania Nicola Smania, Doctor principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GangTrainer and tDCS in people with Hemiparesis and Cerebrovascular Disorders, run by Universita di Verona at 1 site in Italy.

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 9 inclusion and 8 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 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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. Some participants in this study may receive a placebo. 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?

Motricity Index (time frame: All patients enrolled in the study will be evaluated before the beginning (baseline time 0) of treatment and after the end (after 6 weeks) of the treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01040299, which also lists 3 linked publications.

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 26 Mar 2012; AzTrials last refreshed its copy on 6 Nov 2026.