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StrokeNCT07066319

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

A study testing Gait Training with Proprioceptive Neuromuscular Facilitation (PNF), Gait Training with Conventional Physiotherapy and Combined PNF and Conventional Physiotherapy (without direct gait training) in people with Stroke, run by University of Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Stroke
What is being tested?
Gait Training with Proprioceptive Neuromuscular Facilitation (PNF), Gait Training with Conventional Physiotherapy and Combined PNF and Conventional Physiotherapy (without direct gait training)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 sitePakistan
Study dates
15 Oct 2024to 25 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Sehat Medical Complex, Hanjarwal, UOL

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

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:

Read more

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.

Read the detailed description

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.

Conditions
Stroke
Being tested
Gait Training with Proprioceptive Neuromuscular Facilitation (PNF), Gait Training with Conventional Physiotherapy, Combined PNF and Conventional Physiotherapy (without direct gait training)
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
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)Behavioural

    Also called PNF Gait Therapy, Neuromuscular Gait Facilitation

    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.

  • Gait Training with Conventional PhysiotherapyBehavioural

    Also called CPT Gait Training, Standard Physiotherapy for Stroke

    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.

  • Combined PNF and Conventional Physiotherapy (without direct gait training)Behavioural

    Also called PNF+CPT Stroke Rehab, Hybrid Motor Recovery Therapy

    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.

Study groups in NCT07066319
Study groupRoleWhat they receive
Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)ExperimentalParticipants 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.
Receives: Behavioral: Gait Training with Proprioceptive Neuromuscular Facilitation (PNF)
Gait Training with Conventional Physical TherapyExperimentalParticipants 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.
Receives: Behavioral: Gait Training with Conventional Physiotherapy
Combined PNF and Conventional PhysiotherapyExperimentalThis 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.
Receives: Behavioral: Combined PNF and Conventional Physiotherapy (without direct gait training)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 weeks, and 6 weeks post-intervention

  2. 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.

    Measured: Baseline, 3 weeks, and 6 weeks post-intervention

  3. 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.

    Measured: Baseline, 3 weeks, and 6 weeks post-intervention

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

    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.

    Measured: Baseline, 3 weeks, and 6 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start15 Oct 2024
  3. Primary completion23 May 2025
  4. Study completion25 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of three parallel intervention groups. Each group will receive a different physiotherapy protocol without crossover between arms.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07066319
Sponsor's protocol ID
IRB-UOL-SMC/001-36/2024
Status last verified
Jul 2025
First submitted
3 Jul 2025
Last updated
15 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38592172
  • 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.

    PubMed 34168608
  • 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.

    PubMed 33879656

Questions about this trial

What is this clinical trial studying?

A study testing Gait Training with Proprioceptive Neuromuscular Facilitation (PNF), Gait Training with Conventional Physiotherapy and Combined PNF and Conventional Physiotherapy (without direct gait training) in people with Stroke, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Wisconsin Gait Scale (WGS) Scores (time frame: Baseline, 3 weeks, and 6 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07066319, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.

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