Clinical trial NCT06086314: The Effects of Neurorehabilitation Approaches Involving Different Upper Extremity Reactive Trainings in Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Spastic Hemiplegia
Keywords: reactive training
trunk control
balance
fall risk
gait
functional reaching
spasticity
fine dexterity
respiratory function
cognitive function
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 and methods on body control, balance, gait, fall risk, spasticity, upper extremity fine dexterity, respiratory, and cognitive function 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, upper extremity spasticity, upper extremity fine dexterity, respiratory function and cognitive function?

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.

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.

Eligibility criteria: 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 (having normal cognitive status)

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

Primary outcomes:
measure: Trunk Control
timeFrame: 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).
measure: Balance
timeFrame: 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).
measure: Balance and Stability Limits
timeFrame: 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).
measure: Gait
timeFrame: 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).
measure: Fall Risk
timeFrame: 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).
measure: Upper Extremity Spasticity
timeFrame: 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).
Secondary outcomes:
measure: Upper Extremity Fine Dexterity
timeFrame: 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).
measure: Respiratory Function
timeFrame: 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).
measure: Respiratory Muscle Strength
timeFrame: 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).
measure: Cognitive Function
timeFrame: 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).
Other outcomes:
Locations:
city: Gölhisar
country: Turkey
facility: FizyoFi Physiotherapy Consultancy Center
state: Burdur
city: Gölhisar
country: Turkey
facility: Gölhisar Vocational School of Health Sciences
state: Burdur
Study officials:
affiliation: Pamukkale University
name: Nilüfer Çetişli Korkmaz, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.