Augmented Reality for Stroke Rehabilitation

NCT06761781 | Completed

• 1 other identifier: REC/01997 Abrish Habib
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke/Brain Attack

Keywords

Stroke rehabilitation; Augmented reality; Balance; motor function

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment Upper Extremity and Lower Extremity (FMA-UE and FMA-LE);

  The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r 0.99) for determining motor function.

  10 weeks

• Berg Balance Scale (BBS);

  The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

  10 weeks

• Functional Ambulation Category (FAC)

  The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. The FAC is a quick visual measurement of walking, is simple to use, easy to interpret. The test has good interrater reliability (κ=.72) and excellent test-retest reliability (k=.950).

  10 weeks

Secondary Outcomes (3)

• Quality of life (QOL): physical and mental health using the 12-Item Short Form Health Survey (SF 12v2)

  10 weeks

• User experience (UX) using questionnaires (designed based on UEQ-S)

  10 weeks

• Activities of Daily Living (ADL) using the Barthel Index (BI)

  10 weeks

Study Arms (2)

Augmented Reality Training

EXPERIMENTAL

Augmented reality training to Experimental group

Other: Augmented Reality

Traditional Treatment

ACTIVE COMPARATOR

Task based training to the Control Group

Other: Traditional Training

Interventions

Augmented Reality 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.

Augmented Reality Training

Traditional Training 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.

Traditional Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants falling in this category would be recruited into the study.
• 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;
• with motor impairment in the upper limb, lower limb, and/or balance;
• have no or mild spasticity on the lower limb or upper limb assessed by Modified Ashworth Scale (MAS ≤ 2); and
• have sufficient cognition to follow the instructions provided by the therapists and the computer.

You may not qualify if:

• Participants fall in this category would be excluded of the study.
• 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;
• have severe shoulder/arm or hip/knee contracture/ pain and;
• Pregnant women.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46060, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arshad Nawaz Malik, PhD Rehab

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Abrish Habib Abbasi, PhD* Rehab

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Mirza Obaid Baig, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: December 31, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)