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

NCT07066319 | Completed DMC

• 1 other identifier: IRB-UOL-SMC/001-36/2024
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke Rehabilitation; Gait Training; Proprioceptive Neuromuscular Facilitation (PNF); Conventional Physical Therapy; Motor Recovery; Balance Training; Functional Independence; Fugl-Meyer Assessment; Berg Balance Scale; Wisconsin Gait Scale; Functional Independence Measure (FIM); Lower Limb Motor Function; Neurorehabilitation; Stroke Survivors; Physiotherapy

Outcome Measures

Primary Outcomes (3)

• Change in Wisconsin Gait Scale (WGS) Scores

  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.

  Baseline, 3 weeks, and 6 weeks post-intervention

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

  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.

  Baseline, 3 weeks, and 6 weeks post-intervention

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

  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.

  Baseline, 3 weeks, and 6 weeks post-intervention

Secondary Outcomes (1)

• Change in Balance Performance from the Berg Balance Scale (BBS)

  Baseline, 3 weeks, and 6 weeks post-intervention

Other Outcomes (1)

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

  Baseline, 3 weeks, and 6 weeks post-intervention

Study Arms (3)

Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)

EXPERIMENTAL

Participants in this arm will receive gait training integrated with Proprioceptive Neuromuscular Facilitation (PNF) techniques. The intervention will be delivered over 12 weeks, with sessions lasting 45 minutes, three times per week. Each session includes a 10-minute warm-up, 30 minutes of PNF-based gait training involving diagonal movement patterns and resistance exercises, and a 5-minute cool-down. Manual resistance and verbal cueing will be used to promote motor control, postural alignment, and dynamic stability.

Behavioral: Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)

Gait Training with Conventional Physical Therapy

EXPERIMENTAL

Participants in this group will receive structured gait training alongside conventional physiotherapy techniques. Sessions will be conducted three times per week for 12 weeks, each lasting 45 minutes. The protocol includes a 10-minute warm-up with flexibility and balance activities, 30 minutes of gait-focused exercises (e.g., step training, overground walking), and a 5-minute cool-down. Conventional PT methods such as strengthening, ROM exercises, and functional mobility drills will be used to improve gait performance and lower limb function.

Behavioral: Gait Training with Conventional Physiotherapy

Combined PNF and Conventional Physiotherapy

EXPERIMENTAL

This group will receive a hybrid intervention combining Proprioceptive Neuromuscular Facilitation (PNF) and conventional physiotherapy techniques. Each session will last 45 minutes, three times per week for 12 weeks. The intervention includes a 10-minute PNF warm-up, 25 minutes of integrated gait training and functional exercises (balance, strengthening, mobility), and a 10-minute cool-down. The goal is to maximize motor recovery, neuromuscular coordination, and balance in stroke survivors.

Behavioral: Combined PNF and Conventional Physiotherapy (without direct gait training)

Interventions

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.

Also known as: PNF Gait Therapy, Neuromuscular Gait Facilitation

Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)

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.

Also known as: CPT Gait Training, Standard Physiotherapy for Stroke

Gait Training with Conventional Physical Therapy

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.

Also known as: PNF+CPT Stroke Rehab, Hybrid Motor Recovery Therapy

Combined PNF and Conventional Physiotherapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sehat Medical Complex, Hanjarwal, UOL

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

• Teodoro J, Fernandes S, Castro C, Fernandes JB. Current Trends in Gait Rehabilitation for Stroke Survivors: A Scoping Review of Randomized Controlled Trials. J Clin Med. 2024 Feb 27;13(5):1358. doi: 10.3390/jcm13051358.

  PMID: 38592172 BACKGROUND

• Mohan DM, Khandoker AH, Wasti SA, Ismail Ibrahim Ismail Alali S, Jelinek HF, Khalaf K. Assessment Methods of Post-stroke Gait: A Scoping Review of Technology-Driven Approaches to Gait Characterization and Analysis. Front Neurol. 2021 Jun 8;12:650024. doi: 10.3389/fneur.2021.650024. eCollection 2021.

  PMID: 34168608 BACKGROUND

• Kim CH, Chu H, Kang GH, Kim KH, Lee YU, Lim HS, Sung KK, Lee S. Comparison of gait recovery patterns according to the paralyzed side in stroke patients: An observational study based on a retrospective chart review (STROBE compliant). Medicine (Baltimore). 2021 Apr 23;100(16):e25212. doi: 10.1097/MD.0000000000025212.

  PMID: 33879656 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Participants will be randomly assigned to one of three parallel intervention groups. Each group will receive a different physiotherapy protocol without crossover between arms.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: October 15, 2024
• Primary Completion: May 23, 2025
• Study Completion: June 25, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)