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Completed

NCT Number: NCT07066319

Impact of Gait Training on Lower Extremity Motor Function and Balance Performance in Stroke Survivors.

This randomized clinical trial evaluates and compares the effectiveness of three physiotherapy-based rehabilitation strategies in improving gait, motor function, balance, and independence in individuals recovering from stroke. Stroke survivors often face challenges such as impaired walking, weak lower limbs, and poor postural control. Combining targeted interventions such as Proprioceptive Neuromuscular Facilitation (PNF) and Conventional Physical Therapy (CPT) may enhance functional outcomes.

Ninety-nine participants were randomly assigned to one of three groups:

Group A received Gait Training with PNF.

Group B received Gait Training with Conventional Physiotherapy.

Group C received a hybrid intervention combining PNF and Conventional Physiotherapy.

All interventions were delivered over 12 weeks, in 45-minute sessions conducted three times per week. Assessments were conducted at baseline, 3 weeks, and 6 weeks post-intervention.

The study used validated tools to measure progress in walking quality (Wisconsin Gait Scale - WGS), lower limb motor recovery (Fugl-Meyer Assessment - FMA-LE), balance (Berg Balance Scale - BBS), and daily functional ability (Functional Independence Measure - FIM).

To enable in-depth analysis, six outcome domains were created by combining different pairs of these tools:

A1: WGS + FMA-LE + FIM + BBS (overall recovery)

A2: WGS + BBS (gait and balance)

A3: WGS + FMA-LE (gait and motor recovery)

A4: BBS + FMA-LE (balance and motor recovery)

A5: WGS + FIM (gait and functional independence)

A6: BBS + FIM (balance and independence)

This study aims to identify the most effective rehabilitation strategy among the three to support physical recovery and improve independence in post-stroke individuals.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sehat Medical Complex, Hanjarwal, UOL

Lahore, Punjab Province, 54000, Pakistan

About this study

This randomized clinical trial was conducted to investigate the comparative effects of three distinct gait-focused rehabilitation protocols on lower extremity motor function, balance performance, and functional independence in stroke survivors. The trial was carried out at the Department of Physiotherapy, Sehat Medical Complex, Hanjarwal, Lahore, over six months, following ethical approval.

A total sample of 99 participants was determined using G*Power, accounting for a 15% dropout rate. The participants were randomly allocated to one of three intervention groups (n=33 per group). Inclusion criteria required participants to be aged 40-80 years, have a confirmed diagnosis of stroke (ischemic or hemorrhagic), be at least 3 months post-stroke, and capable of understanding commands (GCS ≥ 9). Exclusion criteria included history of multiple strokes, significant comorbidities, or severe mobility or cognitive limitations.

Intervention Groups:

Group A (Gait Training + PNF):

45-minute sessions, 3 times per week for 12 weeks, combining dynamic gait training with PNF techniques such as diagonal movement patterns, rhythmic initiation, and manual resistance to enhance neuromuscular control and coordination.

Group B (Gait Training + Conventional Physiotherapy):

Participants underwent overground walking, step drills, strength and balance exercises, sit-to-stand transitions, and joint mobilizations to improve postural control, muscle strength, and walking pattern.

Group C (PNF + Conventional Physiotherapy):

This group received PNF-based resistance and rhythmic stabilization along with traditional exercises (e.g., mobility drills, resistance training, flexibility work), excluding direct gait training.

Each protocol targeted specific recovery domains, progressing in intensity and complexity over time. Functional and motor outcomes were assessed using:

Wisconsin Gait Scale (WGS) for gait performance

Fugl-Meyer Assessment - Lower Extremity (FMA-LE) for motor recovery

Berg Balance Scale (BBS) for balance assessment

Functional Independence Measure (FIM) for daily functional capability

To allow for a comprehensive evaluation, outcome data were analyzed under six analytical combinations:

A1: All four measures combined (WGS, FMA-LE, FIM, BBS)

A2: Gait and balance (WGS + BBS)

A3: Gait and motor recovery (WGS + FMA-LE)

A4: Balance and motor recovery (BBS + FMA-LE)

A5: Gait and functional independence (WGS + FIM)

A6: Balance and independence (BBS + FIM)

Statistical Analysis:

Data were processed using SPSS Version 24. Descriptive statistics summarized demographic data. The Kolmogorov-Smirnov test assessed data normality. Paired t-tests and ANOVA were applied to normally distributed data, while Mann-Whitney U and Wilcoxon tests were used for non-parametric comparisons. A p-value < 0.05 was considered statistically significant.

This trial aims to determine which physiotherapy combination is most effective in promoting recovery of walking ability, balance, and independence, with potential implications for developing best-practice rehabilitation protocols for stroke survivors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 40 to 80 years
  • Both males and females
  • Clinically confirmed diagnosis of ischemic or hemorrhagic stroke, verified through CT or MRI (Teodoro et al., 2024)
  • At least three months post-stroke to ensure clinical stability
  • Residing in the community (not in acute or long-term care facilities)
  • Able to understand and follow instructions, assessed by a Glasgow Coma
  • Scale (GCS) score of 9 or above (Kim et al., 2021)
  • Able to perform basic mobility tasks independently, such as standing, walking short distances, and transferring

Exclusion criteria

  • Diagnosis of other neurological disorders such as Parkinson's disease or multiple sclerosis
  • History of more than one previous stroke
  • GCS score below 9, indicating significant cognitive impairment
  • Inability to perform basic mobility tasks without assistance
  • Presence of severe comorbidities that may impact recovery, such as uncontrolled diabetes or cardiovascular disease
  • History of major surgery within the last three months
  • Participants in acute or long-term care settings rather than home or community settings (Stephenson et al., 2014; Kim et al., 2022)

Treatment and study plan

Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)

Behavioral

A physiotherapeutic intervention combining structured gait training with Proprioceptive Neuromuscular Facilitation (PNF) techniques. Sessions include rhythmic initiation, diagonal movement patterns, and resistance-based facilitation to enhance lower limb motor control and balance in stroke survivors. Delivered 3 times/week for 12 weeks, 45 minutes per session.

Other names: PNF Gait Therapy, Neuromuscular Gait Facilitation

Gait Training with Conventional Physiotherapy

Behavioral

A rehabilitation protocol integrating traditional gait training (step drills, overground walking) with conventional physiotherapy exercises focused on lower limb strength, range of motion, and postural balance. Conducted over 12 weeks, 3 sessions per week, 45 minutes each.

Other names: CPT Gait Training, Standard Physiotherapy for Stroke

Combined PNF and Conventional Physiotherapy (without direct gait training)

Behavioral

This intervention blends Proprioceptive Neuromuscular Facilitation (PNF) with conventional physiotherapy, excluding dedicated gait tasks. It includes rhythmic stabilization, functional mobility drills, and resistance-based exercises aimed at improving neuromuscular re-education, balance, and independence. Delivered 3 times/week for 12 weeks, 45 minutes per session.

Other names: PNF+CPT Stroke Rehab, Hybrid Motor Recovery Therapy

Primary outcomes

  1. Change in Wisconsin Gait Scale (WGS) Scores

    Time frame: Baseline, 3 weeks, and 6 weeks post-intervention

    The WGS evaluates gait deviations in stroke survivors. This outcome assesses improvements in gait pattern, weight transfer, and limb advancement. A lower score post-intervention indicates improved gait function.

  2. Change in Mobility Level (MBL) from the Functional Independence Measure (FIM)

    Time frame: Baseline, 3 weeks, and 6 weeks post-intervention

    The mobility subscale of the FIM assesses transfers, locomotion, and walking independence. A higher score post-treatment indicates reduced caregiver dependence and greater functional mobility.

  3. Change in Lower Extremity Motor Function (LEMF) from the Fugl-Meyer Assessment (FMA-LE)

    Time frame: Baseline, 3 weeks, and 6 weeks post-intervention

    The FMA-LE evaluates reflexes, voluntary movement, coordination, and speed in the lower limbs post-stroke. Improvement in scores reflects enhanced neuromuscular recovery and motor control.

Secondary outcomes

  1. Change in Balance Performance from the Berg Balance Scale (BBS)

    Time frame: Baseline, 3 weeks, and 6 weeks post-intervention

    The BBS assesses static and dynamic balance through 14 tasks such as standing, reaching, and turning. Improved scores indicate better postural control and reduced fall risk in stroke survivors.

Other outcomes

  1. Composite Score Analysis of Combined Functional Measures (A1-A6)

    Time frame: Baseline, 3 weeks, and 6 weeks post-intervention

    To provide a comprehensive evaluation of intervention outcomes, composite scoring analyses will be conducted using six pre-specified combinations of validated tools:

    A1: WGS + FMA-LE + FIM + BBS A2: WGS + BBS A3: WGS + FMA-LE A4: BBS + FMA-LE A5: WGS + FIM A6: BBS + FIM These combinations allow for domain-specific evaluation of gait, motor function, balance, and independence, and will be used to detect multi-domain changes across intervention groups.

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

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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