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NCT Number: NCT06696950

Multimodal Gait Training With and Without Rhythmic Auditory Stimulation in Chronic Stroke Patients

The primary goal of this randomized clinical trial is to investigate the efficacy of multimodal gait training, with and without rhythmic auditory stimulation, in improving gait, coordination and reducing fall risk in individuals with chronic stroke This clinical trial features two distinct groups 42 participants were randomly divided into two groups of 21. Group A will receive Multimodal gait training along with rhythmic auditory stimulation while Group B will receive only multimodal gait training

Participants will:

* Take 12 sessions of the MMGT program over six weeks * With each session lasting 45 minutes, including 10-minute rest breaks.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Stroke Patients

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal Memorial Hospital, Islam teaching hospital, National Bone joint Hospital, Amra Medical Center

Sialkot, Punjab Province, 51040, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of age between 45 and 70 year
  • Participants of both genders were included.
  • Participants who were able to walk independently indoors without walking aid
  • Participants were included if they had lower limb motor impairment (Fugl-Meyer Assessment lower extremity (FMLE) score less than score less than 34
  • Participants with stroke lasting longer than six months
  • Participants with Mini-Mental Status Examination score 24 or more than 24
  • Participants with the capability to keep in sitting position for 30 minutes
  • Participants with the history of fall in the past year
  • Participants with no visual or auditory impairments that would interfere with the training

Exclusion criteria

  • Participants with respiratory problems.
  • Participants with any orthopedic condition.
  • Participants with aphasia that impeded communication.
  • Participants with have severe cardiac disease.
  • Participants with resistant hypertension despite use of medication (average systolic blood pressure ≥ 140 mmHg or average diastolic blood pressure ≥ 90 mmHg measured over 7 days)
  • Participants with presence of non-healing ulcers in the lower limbs, and osteoporosis

Treatment and study plan

Mutimodal gait training includes unilateral step training, inclined treadmill training, over ground training with rhythmic auditory stimulation

Other

Unilateral step training, inclined treadmill training, over ground training, repetitive isochronous pulses via metronome

Multimodal gait training

Other

Unilateral step training, inclined treadmill training, over ground training,

Primary outcomes

  1. LOWER EXTREMITY MOTOR COORDINATON TEST (LEMCOT)

    Time frame: 6 weeks

    The Lower Extremity Motor Coordination test (LEMCOT) is a clinically useful performance-based test to assess coordination improvements of lower limb in post-stroke individuals

  2. Dynamic gait index (DGI)

    Time frame: 6 weeks

    The dynamic gait index is a comprehensive clinical assessment performance based tool used designed to evaluate gait-related task such as dynamic balance, gait and risk of fall in older adults with various neurological conditions

  3. Fall Efficacy Scale-International (FES-I)

    Time frame: 6 weeks

    Fall efficacy scale-international (FES- I) is a standardized, short and easy to administer tool evaluates fear of falling and measures concerns about falling

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Multimodal Gait Training With and Without Rhythmic Auditory Stimulation on Coordination, Gait and Risk of Fall in Chronic Stroke Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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