Effects of Unilateral Step Training on Gait and Balance in Stroke Patients

NCT05449301 | Completed DMC

• 1 other identifier: REC/01203 Sana Khalid
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

According to the definition proposed by the World Health Organization, "stroke is rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer, or leading to death, with no apparent cause other than of vascular origin". Difficulty in walking is present in approximately 80% of stroke survivors. 25% of stroke survivors even after getting rehabilitation have residual gait impairments requiring full assistance after hospital discharge resulting in difficulties in performing basic activities of daily life. Approaches to gait rehabilitation are different based on different models of motor physiology and disease recovery, but most of the approaches are targeting motor impairments during straight walking only as opposed to adaptive walking ability . In order to decrease health care burden effective rehabilitation and prevention is necessary. Multidisciplinary care dedicated for stroke leads to higher independence rates. Conventional gait training regimes including linear parallel bar based gait training and treadmill based gait training protocols do not usually target the angular or rotational component of locomotion. Current study will focus on Unilateral Step Training using a traditional treadmill. This would provide a targeted gait training tool to reduce the risk of fall, improve gait and turning ability and functional activity eventually resulting in greater community participation and involvement in occupational activities. Such an approach could be effective in providing an early targeted and intense training environment similar to task-specific training in contrast to conventional method.

Conditions

Stroke

Keywords

Balance; Gait; Mobility

Outcome Measures

Primary Outcomes (6)

• 3D clinical gait assessment (Motion Metrix)

  MotionMetrix's 3D Clinical Gait system provides a standard set of gait parameters in which most pathological conditions are reflected. Clinicians can therefore use it to efficiently screen for a variety of conditions and to follow up on corrective measures.

  12 weeks

• Wisconsin gait

  Wisconsin Gait Scale (WGS) is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.

  12 weeks

• Figure of eight walk test

  The Figure of 8 Walk Test (F8WT) measures the everyday walking ability with mobility disability. The F8WT tests a participant's gait in both straight and curved paths (r=0.81). The F8WT uses a path where the participant is asked to walk a figure of eight shape around two cones. Scores are recorded in three areas: 1) speed (time for completion), 2) amplitude (number of steps taken), and 3) accuracy or "smoothness".

  12 weeks

• Biodex balance system

  it is used to assess objectively balance and also improving balance, increasing agility, developing muscle tone, treating a wide variety of pathologies. it is easy-to-follow "touchscreen" operation, the Balance System is simple to operate, leading the user step-by-step in testing protocols and training modes in both static and dynamic formats

  12 weeks

• Timed Up and Go Test

  The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down

  12 weeks

• Berg Balance Scale

  The Berg Balance Scale assesses the balance of patients with different neurological disorders. Performance is assessed on different tasks and each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.

  12 weeks

Secondary Outcomes (2)

• Fugl-Meyer Assessment (FMA)

  12 weeks

• Stroke specific quality of life

  12 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

The control group will receive Conventional Treadmill training for Gait \& balance impairment.

Other: Treadmill Training

Rhythmic Auditory Stimulation Training Group

EXPERIMENTAL

Participants will be trained conventionally (bipedal) on regular treadmill along with Rhythmic Auditory Stimulation.

Other: Rhythmic Auditory Stimulation; Other: Treadmill Training

Unilateral Step Training Group

EXPERIMENTAL

The participants will be trained with regular treadmill for unilateral step for both paretic and non-paretic lower extremity

Other: Unilateral Step Training

Interventions

Treadmill Training OTHER

participants will be trained conventionally (bipedal) on regular treadmill. one session per day, 3 session per week for consecutively 12 weeks.

Control Group; Rhythmic Auditory Stimulation Training Group

Rhythmic Auditory Stimulation OTHER

The participants will receive RAS on regular treadmill for balance and gait improvement. one session per day, 3 session per week for consecutively 12 weeks.

Rhythmic Auditory Stimulation Training Group

Unilateral Step Training OTHER

Patients will be trained on regular treadmill for both paretic and non paretic lower extremity. Single session per day, 3 session per week for consecutively 12 weeks.

Unilateral Step Training Group

Eligibility Criteria

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

You may qualify if:

• Both Genders.
• Age: 40-60 years
• Ischemic stroke
• Patients having stroke involving Middle Cerebral Artery
• Patients in sub-acute (3 months) and chronic phase (6 months) of stroke
• Mini-Mental State Exam score \> 24
• Functional Ambulatory Capacity: 3-5

You may not qualify if:

• Patients with unstable medical conditions (e.g., DVT, uncontrolled hypertension, uncontrolled diabetes and musculoskeletal injuries)
• History of other diseases known to interfere with participation in the study (e.g., heart failure, epilepsy)
• Participants with cognitive impairment.
• Score of muscle tone on Modified Ashworth Scale: 3-4

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

Related Publications (1)

• Khalid S, Malik AN, Siddiqi FA. Effects of unilateral step training along with rhythmic auditory stimulation on balance and postural stability in stroke patients. Sci Rep. 2026 Mar 9. doi: 10.1038/s41598-026-41790-y. Online ahead of print.

  PMID: 41803234 DERIVED

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 N Malik, PhD

  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: July 4, 2022
• First Posted: July 8, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)