Effects Of Functional Action Observation With Auditory Cueing In Stroke Patients

NCT07428824 | Recruiting DMC

• 1 other identifier: REC/0286 Shirin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to determine the effects of functional action observation therapy with and without rhythmic auditory cueing on balance and gait in patients with stroke. A randomized clinical trial will be conducted at Ittefaq Hospital Trust, Lahore and Alara Healthcare Clinic. The sample size will be 40. The non-probability convenience sampling methodology will be used to select participants who match the inclusion criteria and the online randomization will be used to further randomize them.Participants will be divided into 2 groups, 20 patients in clinical group and 20 patients in experimental group. While the clinical group will receive traditional therapy, the experimental group will receive Funtional Action Observation Therapy with auditory cueing. For four weeks, the subjects underwent 30 minutes of FAO or general action observation (GAO) instruction five times a week. The outcome measures will include assessments of balance and gait using Berg Balance Scale and Functional Gait Assessment. Assessments will be conducted on patients both before and after the intervention to identify any notable variations in their gait and balance

Conditions

Stroke

Keywords

Balance; Neuroplasticity; Rehabilitation; Stroke

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale

  The 14 items in the BBS include both static and dynamic tasks with different levels of complexity. The highest test score is 56, and each item is given a score between 0 and 4. Higher scores indicate greater balance ability. The test is great for assessing falls and gait speed in chronic stroke patients, and it has excellent validity and reliability in stroke patients. BBS's alpha coefficient is 0.79, which indicates strong internal consistency

  Baseline

• Berg Balance Scale

  The 14 items in the BBS include both static and dynamic tasks with different levels of complexity. The highest test score is 56, and each item is given a score between 0 and 4. Higher scores indicate greater balance ability. The test is great for assessing falls and gait speed in chronic stroke patients, and it has excellent validity and reliability in stroke patients. BBS's alpha coefficient is 0.79, which indicates strong internal consistency

  4 weeks

Secondary Outcomes (2)

• Functional Gait Assessment

  Baseline

• Functional Gait Assessment

  4 weeks

Study Arms (2)

Eperimental Group A

EXPERIMENTAL

Functional Action Observation Therapy

Other: Functional Action Observation Therapy

Eperimental Group B

EXPERIMENTAL

Functional Action Observation Therapy with rhythmic auditory stimulation

Other: Functional Action Observation Therapy with rhythmic auditory stimulation group

Interventions

Functional Action Observation Therapy OTHER

Group A will receive a session of Functional Action Observation Therapy. Treatment session will be given 30 mins starting with 5 mins warm up and ending with 5 mins cool down. During 30 mins exercise participant will watch videos of functional activities for 15 min and then perform those activities for 15 mins with 30 secs rest after every activity

Eperimental Group A

Functional Action Observation Therapy with rhythmic auditory stimulation group OTHER

Group B will receive a session of Functional Action Observation Therapy with rhythmic auditory cueing. Treatment session will be given 30 mins starting with 5 mins warm up and ending with 5 mins cool down. During 30 mins exercise participant will watch videos of functional activities with rhythmic auditory cueing for 15 min and then perform those activities for 15 mins with 30 secs rest after every activity.

Eperimental Group B

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 40 to 60 years
• Both male and female patients are included in the study
• months to 2 years since the onset of stroke
• Ability to sit and stand up independently
• Ability to walk more than 10 m, with or without an assistant device
• No orthopedic impairments on both lower

You may not qualify if:

• Subjects with MMSE score less than 25
• a positive history of neoplasms, cardiovascular disease, respiratory disease clinically significant muscular-skeletal disease
• uncorrected visual or auditory disturbances
• hospitalization in the previous three months
• Patients with aggressive behavioral alterations or emotional lability

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Alara Healthcare Clinic

Lahore, Punjab Province, Pakistan

RECRUITING

Ittefaq Hospital Trust, Lahore

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

• Errante A, Saviola D, Cantoni M, Iannuzzelli K, Ziccarelli S, Togni F, Simonini M, Malchiodi C, Bertoni D, Inzaghi MG, Bozzetti F, Menozzi R, Quarenghi A, Quarenghi P, Bosone D, Fogassi L, Salvi GP, De Tanti A. Effectiveness of action observation therapy based on virtual reality technology in the motor rehabilitation of paretic stroke patients: a randomized clinical trial. BMC Neurol. 2022 Mar 22;22(1):109. doi: 10.1186/s12883-022-02640-2.

  PMID: 35317736 BACKGROUND

• Mainka S, Wissel J, Voller H, Evers S. The Use of Rhythmic Auditory Stimulation to Optimize Treadmill Training for Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Sep 14;9:755. doi: 10.3389/fneur.2018.00755. eCollection 2018.

  PMID: 30271375 BACKGROUND

• Gonzalez-Hoelling S, Reig-Garcia G, Bertran-Noguer C, Suner-Soler R. The effects of rhythmic auditory stimulation on functional ambulation after stroke: a systematic review. BMC Complement Med Ther. 2024 Jan 20;24(1):45. doi: 10.1186/s12906-023-04310-3.

  PMID: 38245704 BACKGROUND

• Scataglini S, Van Dyck Z, Declercq V, Van Cleemput G, Struyf N, Truijen S. Effect of Music Based Therapy Rhythmic Auditory Stimulation (RAS) Using Wearable Device in Rehabilitation of Neurological Patients: A Systematic Review. Sensors (Basel). 2023 Jun 26;23(13):5933. doi: 10.3390/s23135933.

  PMID: 37447782 BACKGROUND

• Roelofs JMB, Zandvliet SB, Schut IM, Huisinga ACM, Schouten AC, Hendricks HT, de Kam D, Aerden LAM, Bussmann JBJ, Geurts ACH, Weerdesteyn V. Mild Stroke, Serious Problems: Limitations in Balance and Gait Capacity and the Impact on Fall Rate, and Physical Activity. Neurorehabil Neural Repair. 2023 Dec;37(11-12):786-798. doi: 10.1177/15459683231207360. Epub 2023 Oct 25.

  PMID: 37877724 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Binash Afzal, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirin Kamran, MSPT-NM

CONTACT

03114759567; shirinkamran786@gmail.com

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: December 8, 2025
• First Posted: February 24, 2026
• Study Start: November 5, 2025
• Primary Completion: April 12, 2026
• Study Completion: April 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)