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IRCT20240406061422N1 IRCT 2024-08-05 Shahid Beheshti University of Medical Sciences Comparison of the effect of a Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention versus real PNF exercises in stroke Comparison of the effect of a Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention versus real PNF exercises on motor, cognitive and occupational performance in chronic stroke survivors 2024-08-05 anticipated 28 Complete https://irct.ir/trial/76342 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering the impact of gender on some of the variables, participants are initially divided into two categories based on gender. Then, within each category, patients are randomly assigned in equal numbers to one of two intervention groups ,PNFbased virtual reality intervention group and the real PNFexercises group, using block randomization of size 4.The criterion for choosing each of the 6 possible block states is rolling a dice. That is, two patients out of4similar patients are assigned to the intervention group in the virtual environment and the other two are assigned to the real exercise group. This process continues until the patients are grouped by gender into two homogeneous groups and, additionally, the numbers in both groups are made equal, Blinding description: The evaluation process will be performed by another master's student with clinical experience in patients with neurological disorders, who is not aware of how patients are assigned to groups. N/A Chronic Stroke Survivors. Intervention 1: Intervention group: Participants in the Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention group receive 24 sessions of intervention over 8 weeks. At the first of each session, they receive conventional interventions for 30 minutes. Then, they also receive a 30-minute PNF intervention through the smart rehabilitation system Sana at the Mowafaghian rehabilitation center. The kinetic camera of this virtual reality tool determines the joint angles of the patient and presents them as an avatar on the screen, providing one-handed and two-handed exercises in the form of reaching, tracking, and rotation scenarios. These exercises are designed based on diagonal patterns of the upper limbs in PNF approach. Colorful balls of various sizes appear as targets on the screen during the exercises, and the patients follow PNF patterns to complete the exercises. The precision, repetition, and speed of exercise are adjusted according to the therapist's opinion and the patient's progress. Additionally, appropriate auditory and visual feedback is received through the screen based on the individual's performance during the exercises. Intervention 2: Control group: Participants in the real Proprioceptive Neuromuscular Facilitation (PNF) exercises group will receive 24 sessions of occupational therapy intervention over 8 weeks, and receive 30 minutes of conventional occupational therapy interventions at the first of each session. They will then perform the same PNF-based exercises in a real manner for 30 minutes. Balls will be used to simulate scenarios of virtual reality tools in the therapeutic environment, and in the same form of reaching, tracking, and rotation scenarios the ball in diagonal patterns of the upper limbs in PNF approach will be executed by the patients. The precision, repetition, and speed of exercise will be adjusted according to the therapist's opinion and the patient's progress, and feedbacks provide by the therapist. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fatemeh Sadat Hosseini Ramshe
School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, in front of Bu Ali Hospital, Damavand St, Imam Hossein Square
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 fatemehosseini@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr Mahnaz Hejazi
School of Rehabilitation Sciences Shahid Beheshti University of Medical Sciences, in front of Bu Ali Hospital, Damavand St, Imam Hossein Square
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 m.hejazishirmard@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) First stroke experience A minimum of 6 months to a maximum of 4 years since stroke Ability to sit independently on a chair during the intervention Ability to understand and follow instructions Brunnstrom stage 3 or higher for upper extremity 18 years 64 years Both Severe visual impairment that makes it difficult to interact with virtual reality tool History of previous mood disorders or use of related medications I64 Stroke, not specified as haemorrhage or infarction Rehabilitation Rehabilitation Intervention group: Participants in the Proprioceptive Neuromuscular Facilitation (PNF)-based virtual reality intervention group receive 24 sessions of intervention over 8 weeks. At the first of each session, they receive conventional interventions for 30 minutes. Then, they also receive a 30-minute PNF intervention through the smart rehabilitation system Sana at the Mowafaghian rehabilitation center. The kinetic camera of this virtual reality tool determines the joint angles of the patient and presents them as an avatar on the screen, providing one-handed and two-handed exercises in the form of reaching, tracking, and rotation scenarios. These exercises are designed based on diagonal patterns of the upper limbs in PNF approach. Colorful balls of various sizes appear as targets on the screen during the exercises, and the patients follow PNF patterns to complete the exercises. The precision, repetition, and speed of exercise are adjusted according to the therapist's opinion and the patient's progress. Additionally, appropriate auditory and visual feedback is received through the screen based on the individual's performance during the exercises. Control group: Participants in the real Proprioceptive Neuromuscular Facilitation (PNF) exercises group will receive 24 sessions of occupational therapy intervention over 8 weeks, and receive 30 minutes of conventional occupational therapy interventions at the first of each session. They will then perform the same PNF-based exercises in a real manner for 30 minutes. Balls will be used to simulate scenarios of virtual reality tools in the therapeutic environment, and in the same form of reaching, tracking, and rotation scenarios the ball in diagonal patterns of the upper limbs in PNF approach will be executed by the patients. The precision, repetition, and speed of exercise will be adjusted according to the therapist's opinion and the patient's progress, and feedbacks provide by the therapist. Upper Extremity motor performance. Timepoint: Pre ,Post, After 1 month follow up. Method of measurement: Fugl-Meyer Assessment, Motor Activity Log. Cognitive performance. Timepoint: Pre ,Post, After 1 month follow up. Method of measurement: Montreal Cognitive Assessment, Wisconsin Card Sorting Test ,Forward and backward Digit Span Test. Occupational performance. Timepoint: Pre ,Post, After 1 month follow up. Method of measurement: Canadian Occupational Performance Measure. Depression and Anxiety. Timepoint: Pre, Post, After 1 month follow up. Method of measurement: Hospital Anxiety and Depression Scale. Shahid Beheshti University of Medical Sciences Approved 2023-11-12 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Near Taleghani hospital, Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)