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

P

Pamukkale University

Status

Completed

Conditions

Stroke
Spastic Hemiplegia

Treatments

Device: reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program.
Device: reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program
Other: neurorehabilitation program with functional reaching training without device.

Study type

Interventional

Funder types

Other

Identifiers

NCT06086314
26.07.2023-E.396979

Details and patient eligibility

About

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?

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 3 patient groups

reactive exercise training
Experimental group
Description:
They 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.
Treatment:
Device: reactive exercise training with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program
reactive exercise training with co-contraction
Experimental group
Description:
They 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.
Treatment:
Device: reactive exercise training with co-contraction with ''FitPodz Light Trainer'' device in addition to a neurorehabilitation program.
functional reaching training
Active Comparator group
Description:
They 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.
Treatment:
Other: neurorehabilitation program with functional reaching training without device.

Trial contacts and locations

2

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Central trial contact

Fatma Nur Alçın, M.Sc.

Data sourced from clinicaltrials.gov

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