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StrokeNCT06086314

The Effects of Neurorehabilitation Approaches Involving Different Upper Extremity Reactive Trainings in Stroke Patients

A study testing reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program, reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program. and neurorehabilitation program with functional reaching training without device. in people with Stroke and Spastic Hemiplegia, run by Pamukkale University at 2 sites 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 goal of this clinical trial is to investigate the effectiveness of upper extremity training, which is expected for 5 seconds on the target during reaching forward, and to compare the effectiveness of neurorehabilitation interventions including reactive upper extremity trainings to be applied with different speeds… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Spastic Hemiplegia
What is being tested?
reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program, reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program. and neurorehabilitation program with functional reaching training without device.
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesTurkey (Türkiye)
Study dates
13 Nov 2023to 15 Nov 2025
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being between the ages of 18-80
  • ≥3 months after stroke
  • Elbow flexor spasticity ≤2 according to MAS
  • Being able to sit independently and stand with or without walking aid
  • Being an individual with a Functional Ambulation Classification ≥3
  • Being an individual with a Hodkinson Mental Test score ≥6

Who cannot join

  • Presence of another neurological disease that will affect trunk control other than stroke
  • Having acute back or lower extremity pain
  • Having an acute illness (eg vomiting, fever)
  • Recent surgery on the upper-lower extremities or trunk
  • Having a condition or activity restriction that prevents participation in the program
  • Inability to sit or stand independently
  • Having abnormal or unstable cardiovascular responses to exercise
  • Having cognitive impairment

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • FizyoFi Physiotherapy Consultancy Center

    Gölhisar, Burdur, 15000

  • Gölhisar Vocational School of Health Sciences

    Gölhisar, Burdur, 15000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Neurorehabilitation Approaches Involving Different Upper Extremity Reactive Trainings on Trunk Control, Fall Risk and Functionality in Stroke Patients: A Randomized Controlled Double-Blind Study

The goal of this clinical trial is to investigate the effectiveness of upper extremity training, which is expected for 5 seconds on the target during reaching forward, and to compare the effectiveness of neurorehabilitation interventions including reactive upper extremity trainings to be applied with different speeds and methods on body control, balance, gait, fall risk and spasticity in the individuals with stroke. The main questions it aims to answer is:

  • Is there a difference in the effects of neurorehabilitation interventions that include reactive upper extremity trainings applied at different speeds and methods on trunk control, balance, gait, fall risk and upper extremity spasticity?
Read more

All participants will participate in the Bobath Approach-based neurorehabilitation program. This program will include scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity.

  • In addition to the neurorehabilitation program, the 1st and 2nd groups will be given a reaching exercise with LED light reactive training material (Fitpodz Light Trainer®). The LED light sensors, whose duration is set, will light up in green and red colors at random intervals.
  • Patients in the 1st group will be asked to reach forward and touch the sensor when the red light sensor is on, and pull back as soon as the sensor goes out.
  • The patients in the 2nd group will be asked to reach forward and touch the sensor when the green light sensor is lit, and to hold their hand on the sensor for 5 seconds and then withdraw it. With this method, it is aimed to create co-contraction in patients in Group 2.
  • In addition to the neurorehabilitation program, patients in the 3rd group (control group) will have functional stretches to the anterior, right and left while standing.

Researchers will compare three groups to see if there a difference in the effects of neurorehabilitation interventions that include reactive upper extremity trainings applied at different speeds and methods.

Read the detailed description
  • In the trainings of the 1st and 2nd groups, 4 LED light sensors will be placed on the wall at shoulder level in the standing position of the patient. The distance of the patient to the wall will be determined by using the value obtained from the Functional Reach Test according to his or her arm length.
  • The Bobath Approach-based neurorehabilitation training will take 30 minutes per session.
  • After the Bobath Approach-based neurorehabilitation training, all groups will perform 3 sets of training, 10 repetitions per set for each extremity. An equal number of stretches will be made in total in each direction, but the directions will be determined randomly. There will be a 3-minute rest break between sets.
  • All groups will receive training for a total of 7 weeks, 3 sessions per week.
Being tested
reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program, reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program., neurorehabilitation program with functional reaching training without device.
Keywords
reactive training, trunk control, balance, fall risk, gait, functional reaching, spasticity
Medical subject headings
Stroke, Hemiplegia, Muscle Spasticity

What participants receive

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

  • reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation programDevice

    Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Reaching forward and touching the sensor when the red light sensor is on, and withdrawing his/her hand as soon as the sensor goes out.

  • reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program.Device

    Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Reaching forward and touching the sensor when the green light sensor is on, and holding his/her hand on the sensor for 5 seconds and then withdrawing it.

  • neurorehabilitation program with functional reaching training without device.Other

    Attending the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. Doing functional stretching to the anterior, right and left while standing.

Study groups in NCT06086314
Study groupRoleWhat they receive
reactive exercise trainingExperimentalThey will attend the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. After this program, they will receive reactive exercise training with ''FitPodz Light Trainer'' device.
Receives: Device: reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program
reactive exercise training with co-contractionExperimentalThey will attend the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. After this program, they will receive reactive exercise training aimed at creating co-contraction with ''FitPodz Light Trainer'' device.
Receives: Device: reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program.
functional reaching trainingActive comparatorThey will attend the neurorehabilitation program that includes scapula mobilization, trunk elongation training in sitting, and training lumbar stabilizers with bridge activity. After this program, they will receive functional reaching training without device.
Receives: Other: neurorehabilitation program with functional reaching training without device.

What is being measured

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

  1. Trunk Control

    ''Trunk Impairment Scale'' will be used to examine the effectiveness of our treatment results on trunk control. The scale consists of 17 parameters. The sections in the scale are; static sitting balance, dynamic sitting balance, and coordination. It is scored between 0 and 23. 0 is the lowest value and 23 is the highest value and indicates good trunk control.

    Measured: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).

  2. Balance

    ''Mini Balance Evaluation System Test'' will be used to examine the effectiveness of our treatment results on balance. The test consists of four separate categories covering a 14-item assessment. Expected postural control (standing from sitting to standing, standing on tiptoes, standing on one palm), Reactive postural control (forward, backward, lateral compensatory stepping), Sensory orientation (hard surface with eyes open, sponge surface with eyes closed, inclined surface with eyes closed), Dynamic walking (change in walking speed, walking with horizontal head movements, pivoting while walking, stepping over obstacles, Time Up\&Go and Dual Task Time Up\&Go). In evaluating the test, each item is rated on a three-point ordinal scale (ranging from 0 = lowest level of functioning to 2 = normal level of functioning). The total score consists of the sum of the scores obtained from these items and ranges from 0 (worst) to 28 (best).

    Measured: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).

  3. Balance and Stability Limits

    'Funcitonal Reaching Test' will be used to examine the effectiveness of our treatment results on balance and stability limits. In the test, participants are asked to stand in a parallel position near the wall, with their feet shoulder-width apart, make fists with their hands, and flex their shoulders 90 degrees so that they do not touch the wall. The point where the third metacarpal head coincides is recorded as the starting point. He/she is asked to follow the meter fixed to the wall and to reach forward as far as he/she can, so that there is no loss of balance or movement of the feet, and the end point is recorded. It is measured in cm by finding the difference between the starting point and the ending point. The test is repeated 3 times and the average is recorded. This test shows that individuals who cannot reach a distance of 15 cm have a high risk of falling.

    Measured: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).

  4. Gait

    ''Timed Up\&Go'' and ''Dual-Task Timed Up\&Go'' test included in the Mini Balance Evaluation System Test will be used to examine the effectiveness of our treatment results on gait. In the test, the patient is expected to get up from the chair, walk a distance of 3 meters, turn around and sit on the chair again. In the dual-task version, participants are asked to count backward by threes.The elapsed time is recorded in seconds.

    Measured: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).

  5. Fall Risk

    ''The Modified Falls Efficacy Scale'' will be used to examine the effectiveness of our treatment results on fall risk. The scale is an expanded Fall Activity Scale form that includes items questioning confidence during 4 different outdoor activities. The 14 items on the test (10 indoor and 4 outdoor activities) assess confidence when performing different daily tasks. Items on the scale are scored between 0 (not confident) and 10 (completely confident) to assess participants' self-efficacy levels regarding falls.

    Measured: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).

  6. Upper Extremity Spasticity

    Upper extremity spasticity ''Modified Ashworth Scale'' will be used to examine the effectiveness of our treatment results on upper extremity spasticity. The scale is scored from 0 to 5, including the degree (+1). 5 indicates rigidity and 0 indicates no spasticity.

    Measured: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).

Timeline

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

  1. First posted17 Oct 2023
  2. Study start13 Nov 2023
  3. Primary completion15 Nov 2025
  4. Study completion15 Nov 2025

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086314
Sponsor's protocol ID
26.07.2023-E.396979
Status last verified
Jan 2026
First submitted
24 Aug 2023
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.

    PubMed 34635141
  • Lee J, Jeon J, Lee D, Hong J, Yu J, Kim J. Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):435-442. doi: 10.3233/NRE-203133.

    PubMed 33136074
  • Park H, Kim S, Winstein CJ, Gordon J, Schweighofer N. Short-Duration and Intensive Training Improves Long-Term Reaching Performance in Individuals With Chronic Stroke. Neurorehabil Neural Repair. 2016 Jul;30(6):551-61. doi: 10.1177/1545968315606990. Epub 2015 Sep 24.

    PubMed 26405046
  • Shin JW, Don Kim K. The effect of enhanced trunk control on balance and falls through bilateral upper extremity exercises among chronic stroke patients in a standing position. J Phys Ther Sci. 2016 Jan;28(1):194-7. doi: 10.1589/jpts.28.194. Epub 2016 Jan 30.

    PubMed 26957756

Questions about this trial

What is this clinical trial studying?

A study testing reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program, reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program. and neurorehabilitation program with functional reaching training without device. in people with Stroke and Spastic Hemiplegia, run by Pamukkale University at 2 sites 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 6 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Trunk Control (time frame: The first measurement will be made just before starting treatment, and the second measurement will be made 7 weeks after the start of treatment (at the end of treatment).). The study lists 6 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 NCT06086314, which also lists 4 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 21 Jan 2026.

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