Clinical trial NCT06761781: Augmented Reality for Stroke Rehabilitation
Official title: Augmented Reality for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke/Brain Attack
Keywords: Stroke rehabilitation
Augmented reality
Balance
motor function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Primary outcomes:
measure: Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);
timeFrame: 10 weeks
measure: Berg Balance Scale (BBS);
timeFrame: 10 weeks
measure: Functional Ambulation Category (FAC)
timeFrame: 10 weeks
Secondary outcomes:
measure: Quality of life (QOL): physical and mental health using the 12-Item Short Form Health Survey (SF 12v2)
timeFrame: 10 weeks
measure: User experience (UX) using questionnaires (designed based on UEQ-S)
timeFrame: 10 weeks
measure: Activities of Daily Living (ADL) using the Barthel Index (BI)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Arshad Nawaz Malik, PhD Rehab
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Abrish Habib Abbasi, PhD* Rehab
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Mirza Obaid Baig, MS-NMPT
role: PRINCIPAL_INVESTIGATOR
References: