NCT06761638

Brief Summary

This study evaluates the effectiveness of Rhythmic Auditory Stimulation (RAS) therapy versus Task-Specific Training (TST) in enhancing motor function recovery in stroke patients. RAS uses rhythmic cues to aid movement synchronization, while TST focuses on practicing daily tasks to improve functional ability. In a randomized clinical trial, participants were assigned to either RAS or TST groups, with both receiving structured sessions over several weeks.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

December 26, 2024

Last Update Submit

January 5, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Modified Barthel index

    The Modified Barthel Index (MBI) is a crucial tool for assessing functional independence in activities of daily living (ADLs) among patients, particularly those recovering from stroke or other debilitating conditions. It evaluates 10 key self-care and mobility tasks, including feeding, bathing, grooming, dressing, and mobility. Each task is scored based on the level of assistance required, with total scores ranging from 0 (complete dependence) to 100 (complete independence). Higher scores indicate greater independence.

    12 Months

  • Goniometer

    A goniometer is an instrument used to measure the angle of joints in the body, typically to assess the range of motion (ROM). It is commonly used in physical therapy, rehabilitation, and orthopedics to evaluate joint function and monitor progress in patients recovering from injury or surgery. Range of motions of upper limb measured through this goniometer."

    12 Months

Study Arms (2)

Rhythmic Auditory Stimulation Therapy

EXPERIMENTAL
Combination Product: Rhythmic Auditory Stimulation Therapy

Task-Specific Training

EXPERIMENTAL
Combination Product: Task-Specific Training

Interventions

Rhythmic auditory stimulation (RAS) is a therapeutic technique that uses rhythmic auditory cues, like a metronome or music, to improve motor control and coordination. It is often used in rehabilitation for conditions such as stroke, Parkinson's disease, and other movement disorders to enhance gait and other motor functions through the synchronization of movements to auditory rhythms.

Rhythmic Auditory Stimulation Therapy
Task-Specific TrainingCOMBINATION_PRODUCT

Task-specific training is a rehabilitation approach that involves practicing specific tasks or activities to improve the performance of those tasks. It is based on the principle that repetitive practice of functional tasks enhances neuroplasticity, leading to better motor skills and functional recovery, especially in stroke and neurological rehabilitation.

Task-Specific Training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients diagnosed with stroke
  • Age 40-80 years (46)
  • Patients having first ever stroke occurrence
  • Moderate motor function impairments (47)
  • Patients able to follow instruction

You may not qualify if:

  • Patients with severe motor impairments
  • Patients who had cognitive impairments
  • Patients having other neurological conditions and musculoskeletal disorders
  • Patients having history of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 7, 2025

Study Start

February 15, 2024

Primary Completion

July 1, 2024

Study Completion

March 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations