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Stroke, IschemicNCT06715098

Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training Using Gait Analysis and SEMG Measurements

A study testing RoboGait, RehaWalk and Conventional in people with Stroke, Ischemic, run by Pamukkale University at 1 site in Turkey (Türkiye).

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

The aim of our randomized controlled clinical trial was to analyze the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters and lower extremity agonist and antagonist muscle activities in stroke patients and to compare their effectiveness in improving… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic
What is being tested?
RoboGait, RehaWalk and Conventional
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Dec 2023to 28 Sep 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 and above
  • Chronic stage stroke (6 months - 2 years)
  • First stroke
  • Spasticity of Ashworth stage 2 or lower
  • Ability to follow commands
  • Ability to walk unsupported for more than 10 meters
  • No treatment received in the last month

Who cannot join

  • Severe osteoporosis
  • Unstable fracture
  • Excessive spasticity (Ashworth stage 3 and above)
  • Cognitive impairment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Pamukkale University

    Denizli

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training in Chronic Stroke Patients Using Gait Analysis and SEMG Measurements

The aim of our randomized controlled clinical trial was to analyze the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters and lower extremity agonist and antagonist muscle activities in stroke patients and to compare their effectiveness in improving locomotor function. The main questions that the researchers aimed to answer are: What are the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters in stroke patients? What are the effects of robotic-assisted gait training and body-weight-supported treadmill training on lower extremity agonist and antagonist muscle activities in stroke patients? What is the effectiveness of robotic-assisted gait training and body-weight-supported treadmill training in improving locomotor function in stroke patients? The patients included in the study were randomly divided into three groups: The first group received robotic-assisted gait training with RoboGait, the second group received body-weight-supported gait training on a treadmill with RehaWalk, and the third group received conventional walking training.

Being tested
RoboGait, RehaWalk, Conventional
Keywords
Stroke, RehaWalk, RoboGait
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

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

  • RoboGaitDevice

    RoboGait: robotic-assisted gait training

  • RehaWalkDevice

    RehaWalk: body weight-supported treadmill training

  • ConventionalOther

    Conventional: conventional walking training

Study groups in NCT06715098
Study groupRoleWhat they receive
RoboGait groupExperimentalRobotic walking training 3 days a week, 30 minutes a day for 4 weeks
Receives: Device: RoboGait
RehaWalk groupExperimentalWalking training on treadmill with body weight support for 30 minutes a day, 3 days a week for 4 weeks
Receives: Device: RehaWalk
Conventional GroupActive comparatorConventional walking training for 30 minutes a day, 3 days a week for 4 weeks
Receives: Other: Conventional

What is being measured

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

  1. Gait analysis with 2D camera

    Kinematic parameters: Hip joint flexion range of motion degree in the swing phase in the sagittal plane, knee joint maximum flexion angle degree, ankle joint dorsiflexion range of motion degree

    Measured: Change from baseline kinematic parameters at the 4th week after the treatment

  2. Surface Electromyography (sEMG)

    The average EMG (AEMG) amplitude and co-contraction indices (CCI) are calculated for the affected lower extremity's knee flexion and ankle dorsiflexion during the swing phase. CCI is calculated using the formula antagonistic muscle AEMG / (antagonistic muscle AEMG + agonistic muscle AEMG)

    Measured: Change from baseline surface electromyography (sEMG) at the 4th week after the treatment

  3. Pressure and Walking Analysis

    The researchers examined the effects such as walking line length, single support line, forward and backward rollers and lateral symmetry indexes in the pressure analyses. In the gait analysis, walking speed, cadence, step length, step width, foot rotation angle, step duration, double support duration, stance phase, swing phase, single support phase, pre-swing phase, mid-swing phase, terminal swing phase, stance duration, swing duration, double phase, double step length and temporal symmetry index were evaluated. The temporal symmetry index was calculated using the following formula: Swing duration of the affected side of the patient / Swing duration of the unaffected side of the patient

    Measured: Change from baseline pressure and walking analysis at the 4th week after the treatment

Secondary outcomes (3)

  1. The Functional Ambulation Scale (FAS)

    The Functional Ambulation Scale (FAS) is a scale used to assess the level of ambulation in patients. It is divided into six categories graded from 0 to 5: FAS 0: no ambulation, FAS 1-2: unable to walk without assistance, FAS 3-5: able to walk 6 meters independently.

    Measured: Change from baseline FAS at the 4th week after the treatment

  2. For lower extremity, the Fugl-Meyer Assessment (FMA-LE)

    For lower extremity, the Fugl-Meyer Assessment (FMA-LE) was used in our study, consisting of a total of 17 items with a maximum score of 34 points. The scale assesses reflexes, synergy-dependent or synergy-independent voluntary movements, coordination, and speed. Each item is scored between 0 and 2 points, with a higher score indicating better outcomes.

    Measured: Change from baseline FMA-LE at the 4th week after the treatment

  3. The 6-minute walk test (6MWT)

    In the 6-minute walk test (6MWT), researchers asked participants to walk down a 30-meter hospital hallway at their own pace for 6 minutes, following standard instructions to cover as much distance as possible. The distance walked was recorded in meters.

    Measured: Change from baseline 6MWT at the 4th week after the treatment

Timeline

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

  1. First posted4 Dec 2024
  2. Study start14 Dec 2023
  3. Primary completion31 Aug 2024
  4. Study completion28 Sep 2024

Resources

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06715098
Sponsor's protocol ID
PamukkaleU.ftr-FArdıç-001
Status last verified
Nov 2024
First submitted
12 Jul 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.

    PubMed 33076218

  • GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

    PubMed 30871944

  • Stroke, Cerebrovascular accident, WHO. Accessed: 08.10.2023 https://www.emro.who.int/health-topics/stroke-cerebrovascular-accident/index.html

  • Furie K. Epidemiology and Primary Prevention of Stroke. Continuum (Minneap Minn). 2020 Apr;26(2):260-267. doi: 10.1212/CON.0000000000000831.

    PubMed 32224751

  • Buntin MB, Colla CH, Deb P, Sood N, Escarce JJ. Medicare spending and outcomes after postacute care for stroke and hip fracture. Med Care. 2010 Sep;48(9):776-84. doi: 10.1097/MLR.0b013e3181e359df.

    PubMed 20706167

  • Selves C, Stoquart G, Lejeune T. Gait rehabilitation after stroke: review of the evidence of predictors, clinical outcomes and timing for interventions. Acta Neurol Belg. 2020 Aug;120(4):783-790. doi: 10.1007/s13760-020-01320-7. Epub 2020 Mar 12.

    PubMed 32166723

  • Druzbicki M, Przysada G, Guzik A, Brzozowska-Magon A, Kolodziej K, Wolan-Nieroda A, Majewska J, Kwolek A. The Efficacy of Gait Training Using a Body Weight Support Treadmill and Visual Biofeedback in Patients with Subacute Stroke: A Randomized Controlled Trial. Biomed Res Int. 2018 Apr 5;2018:3812602. doi: 10.1155/2018/3812602. eCollection 2018.

    PubMed 29850509

  • Malik AN, Tariq H, Afridi A, Rathore FA. Technological advancements in stroke rehabilitation. J Pak Med Assoc. 2022 Aug;72(8):1672-1674. doi: 10.47391/JPMA.22-90.

    PubMed 36280946

  • Norouzi-Gheidari N, Archambault PS, Fung J. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the literature. J Rehabil Res Dev. 2012;49(4):479-96. doi: 10.1682/jrrd.2010.10.0210.

    PubMed 22773253

  • Schwartz I, Meiner Z. Robotic-assisted gait training in neurological patients: who may benefit? Ann Biomed Eng. 2015 May;43(5):1260-9. doi: 10.1007/s10439-015-1283-x. Epub 2015 Feb 28.

    PubMed 25724733

  • Yoo HJ, Bae CR, Jeong H, Ko MH, Kang YK, Pyun SB. Clinical efficacy of overground powered exoskeleton for gait training in patients with subacute stroke: A randomized controlled pilot trial. Medicine (Baltimore). 2023 Jan 27;102(4):e32761. doi: 10.1097/MD.0000000000032761.

    PubMed 36705351

  • Özbudak Demir S. Robot-Assisted Gait Training for Patients with Spinal Cord Injury. Turk J Phys Med Rehab 2015;61 (Supp. 1):S37-S44.

  • Visintin M, Barbeau H, Korner-Bitensky N, Mayo NE. A new approach to retrain gait in stroke patients through body weight support and treadmill stimulation. Stroke. 1998 Jun;29(6):1122-8. doi: 10.1161/01.str.29.6.1122.

    PubMed 9626282

  • Zhang H, Li X, Gong Y, Wu J, Chen J, Chen W, Pei Z, Zhang W, Dai L, Shu X, Shen C. Three-Dimensional Gait Analysis and sEMG Measures for Robotic-Assisted Gait Training in Subacute Stroke: A Randomized Controlled Trial. Biomed Res Int. 2023 Apr 11;2023:7563802. doi: 10.1155/2023/7563802. eCollection 2023.

    PubMed 37082189

  • Lura DJ, Venglar MC, van Duijn AJ, Csavina KR. Body weight supported treadmill vs. overground gait training for acute stroke gait rehabilitation. Int J Rehabil Res. 2019 Sep;42(3):270-274. doi: 10.1097/MRR.0000000000000357.

    PubMed 31094879

Questions about this trial

What is this clinical trial studying?

A study testing RoboGait, RehaWalk and Conventional in people with Stroke, Ischemic, run by Pamukkale University at 1 site in Turkey (Türkiye).

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 4 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 4 Dec 2024. 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 Turkey (Türkiye). 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?

Gait analysis with 2D camera (time frame: Change from baseline kinematic parameters at the 4th week after the treatment). The study lists 3 primary outcomes in all. 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 NCT06715098, which also lists 29 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 4 Dec 2024.

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