Augmented Reality for Stroke Rehabilitation

NCT ID: NCT06761781

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-03-30

Brief Summary

The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients.

Detailed Description

The study aims to determine the effectiveness of Augmented reality on motor function, balance, and functional ambulation in stroke patients. The emerging technology of Augmented Reality (AR), has been validated as a promising way to assist the rehabilitation training in Stroke patients. The purpose of this study is to investigate the feasibility of the AR rehabilitation system in a real-world setting. The following questions will be addressed by the present study: (a) How the Augmented reality effects motor function, balance, and functional ambulation in stroke patients? (b) how much and what types of manpower can be saved while maintaining the efficacy of training with the assistance of the AR rehabilitation? (c) how can the contact rate be reduced with the AR training? (d) how do therapists/patients experience the AR training?

Conditions

Stroke/Brain Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Augmented Reality Training

Augmented reality training to Experimental group

Group Type: EXPERIMENTAL

Augmented Reality

Intervention Type: OTHER

Each participant will receive a standard trial consisting of 20 training sessions (2-5 sessions per week, 120 min per session) in consecutive 4-10 weeks. Each session will consist of 2-10 exercises selected by the trainer from a pool of 46 exercises. The selected exercises will be tailored based on the participant's condition and progress. The exercise pool will be designed as comprehensively as possible to cover the upper limb (22 exercises and lower limb (7 exercises) motor functions, balance ability (11 exercises), or/and coordination (6 exercises).

Each exercise with a duration ranging from 3 to 23 min, and will be determined by a set of parameters that can be adjusted to the individuals dynamically according to the participant's performance.

Traditional Treatment

Task based training to the Control Group

Group Type: ACTIVE_COMPARATOR

Traditional Training

Intervention Type: OTHER

Each participant will receive a Traditional training based on Task oriented training consisting of 20 training sessions (2-5 sessions per week, 120 min per session) in consecutive 4-10 weeks. Exercises will be tailored based on the participant's condition and progress. The exercises will cover the upper limb, lower limb, motor functions, balance ability and coordination.

Interventions

Augmented Reality

Each participant will receive a standard trial consisting of 20 training sessions (2-5 sessions per week, 120 min per session) in consecutive 4-10 weeks. Each session will consist of 2-10 exercises selected by the trainer from a pool of 46 exercises. The selected exercises will be tailored based on the participant's condition and progress. The exercise pool will be designed as comprehensively as possible to cover the upper limb (22 exercises and lower limb (7 exercises) motor functions, balance ability (11 exercises), or/and coordination (6 exercises).

Each exercise with a duration ranging from 3 to 23 min, and will be determined by a set of parameters that can be adjusted to the individuals dynamically according to the participant's performance.

Intervention Type: OTHER

Traditional Training

Each participant will receive a Traditional training based on Task oriented training consisting of 20 training sessions (2-5 sessions per week, 120 min per session) in consecutive 4-10 weeks. Exercises will be tailored based on the participant's condition and progress. The exercises will cover the upper limb, lower limb, motor functions, balance ability and coordination.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants falling in this category would be recruited into the study.

1. age between 18 to 90 years who are diagnosed with ischemic brain injury, intracerebral hemorrhage shown by magnetic resonance imaging, or computed tomography after the onset of stroke;

2. with motor impairment in the upper limb, lower limb, and/or balance;

3. have no or mild spasticity on the lower limb or upper limb assessed by Modified Ashworth Scale (MAS ≤ 2); and

4. have sufficient cognition to follow the instructions provided by the therapists and the computer.

Exclusion Criteria

Participants fall in this category would be excluded of the study.

1. any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression, epilepsy, artificial cardiac pacemaker/joint;

2. have severe shoulder/arm or hip/knee contracture/ pain and;

3. Pregnant women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arshad Nawaz Malik, PhD Rehab

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Abrish Habib Abbasi, PhD* Rehab

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Mirza Obaid Baig, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/01997 Abrish Habib

Identifier Type: -

Identifier Source: org_study_id