NCT07484438

Brief Summary

This randomized controlled trial aims to compare the effects of task-oriented gait training and core stabilization exercises on mobility, balance, and gait in 54 stroke patients (aged 45-75 years, 6 months to 2 years post-ischemic stroke). Participants with left hemiplegia and MMSE ≥24 will be randomly assigned to either intervention for 8 weeks (3 sessions/week). Outcome measures include the 6-Minute Walk Test, Berg Balance Scale, GAIT, Timed Up and Go Test, and a Patient Satisfaction Survey. Data will be analyzed using SPSS version 25 to determine intervention effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

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

October 18, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

March 16, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • 6-Minute Walk Test (6MWT)

    The 6-Minute Walk Test (6MWT) assesses functional mobility and endurance by measuring walking distance in six minutes, with high reliability in stroke patients (ICC \> 0.90).

    4 weeks

  • Berg Balance Scale (BBS)

    The Berg Balance Scale (BBS) evaluates static and dynamic balance across 14 tasks, serving as a gold standard for fall risk assessment with excellent reliability (ICC = 0.97-0.98).

    4 weeks

  • Gait Assessment and Intervention Tool (GAIT)

    The Gait Assessment and Intervention Tool (GAIT) identifies gait abnormalities such as asymmetry and reduced speed, providing targeted insights for gait rehabilitation (ICC = 0.92).

    4 weeks

  • Timed Up and Go Test (TUG)

    The Timed Up and Go Test (TUG) measures functional mobility and fall risk by timing transitional movements, showing strong reliability (ICC = 0.95).

    4 weeks

Study Arms (2)

Task-Oriented Gait Training

EXPERIMENTAL

It focuses on enhancing functional mobility through real-life walking and movement tasks. The program includes five key exercises: walking practice on flat and uneven surfaces with variations in stride length, speed, and direction; reaching and grasping objects of different sizes and weights from sitting and standing positions; sit-to-stand transitions with minimal arm support; stair navigation with handrail assistance; and object manipulation at varying heights and distances. Each session is conducted three times per week for eight weeks, emphasizing repetition and progression to simulate daily functional activities.

Other: Task-Oriented Gait Training

Core Stabilization Exercises

EXPERIMENTAL

It targets the improvement of balance and postural control through strengthening of trunk muscles. Participants will perform four core-focused exercises: bridging to activate glutes and lower back muscles, pelvic tilts to improve pelvic control and lumbar alignment, side planks for lateral trunk stability, and quadruped (bird-dog) movements to challenge dynamic balance. Exercises are performed in sets with specific repetitions or hold times, progressively increasing in difficulty. The sessions are delivered three times per week for eight weeks to enhance core strength and overall stability in stroke patients.

Other: Core Stabilization Exercises

Interventions

It targets the improvement of balance and postural control through strengthening of trunk muscles. Participants will perform four core-focused exercises: bridging to activate glutes and lower back muscles, pelvic tilts to improve pelvic control and lumbar alignment, side planks for lateral trunk stability, and quadruped (bird-dog) movements to challenge dynamic balance. Exercises are performed in sets with specific repetitions or hold times, progressively increasing in difficulty. The sessions are delivered three times per week for eight weeks to enhance core strength and overall stability in stroke patients.

Core Stabilization Exercises

It focuses on enhancing functional mobility through real-life walking and movement tasks. The program includes five key exercises: walking practice on flat and uneven surfaces with variations in stride length, speed, and direction; reaching and grasping objects of different sizes and weights from sitting and standing positions; sit-to-stand transitions with minimal arm support; stair navigation with handrail assistance; and object manipulation at varying heights and distances. Each session is conducted three times per week for eight weeks, emphasizing repetition and progression to simulate daily functional activities.

Task-Oriented Gait Training

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 45 to 75 years
  • Diagnosed with ischemic stroke
  • Onset of stroke at least 6 months and no more than 2 years prior to enrollment
  • Able to ambulate with or without assistive devices
  • Mini-Mental State Examination (MMSE) score of 24 or higher
  • Experiencing left hemiplegia
  • Able to provide informed consent

You may not qualify if:

  • Other neurological disorders affecting mobility
  • Severe musculoskeletal conditions impacting gait or balance
  • Uncontrolled medical conditions (e.g., severe cardiovascular issues)
  • Major surgery within the last 6 months
  • Current participation in other rehabilitation programs
  • Contraindications to exercise as determined by a healthcare provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sialkot Medical Complex

Sialkot, Punjab Province, 51310, Pakistan

Location

Study Officials

  • Muhammad Ali Hassan Alvi, MS-NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 20, 2026

Study Start

October 18, 2024

Primary Completion

January 25, 2026

Study Completion

February 25, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations