Pelvic-Restricted vs. Pelvic-Free Robot-Assisted Gait Training in Stroke Patients

January 23, 2026 updated by: Meltem Gunes Akinci

Comparison of Pelvic-Free and Pelvic-Restricted Robot-Assisted Gait Training on Walking Pattern, Balance, and Fear of Falling After Stroke

This randomized controlled clinical trial aims to compare the effects of pelvic-free versus pelvic-restricted robot-assisted gait training (RAGT) on gait pattern, balance, and fear of falling in stroke patients. Stroke survivors often experience gait impairments, reduced balance, and fear of falling, which limit independence and quality of life. Conventional physiotherapy requires high intensity and repetition but is restricted by therapist capacity. Robotic gait systems provide intensive, repetitive, and safe training; however, most limit pelvic motion, potentially disrupting natural gait patterns and balance strategies.

A total of 36 participants with chronic stroke (≥6 months post-stroke, age ≥18 years, hemiplegic gait disorder, Functional Ambulation Category ≥2) will be randomized into two groups: (1) pelvic-free RAGT plus conventional rehabilitation, or (2) pelvic-restricted RAGT plus conventional rehabilitation. Interventions will consist of 8 RAGT sessions (twice weekly) and 20 conventional rehabilitation sessions (five times weekly) over 4 weeks.

Primary outcomes include gait analysis parameters (gait speed, step length, cadence, temporal symmetry index) and clinical measures such as the Berg Balance Scale, Functional Ambulation Category, Motricity Index (lower limb), and Falls Efficacy Scale-International. Assessments will be performed at baseline and after 4 weeks of treatment.

The study hypothesizes that pelvic-free RAGT will improve gait symmetry, balance, and reduce fear of falling more effectively than pelvic-restricted training. Results are expected to provide evidence supporting the integration of pelvic-free robotic gait systems into post-stroke rehabilitation to enhance functional recovery and patient confidence

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • History of stroke more than 6 months prior
  • Presence of hemiplegia-related gait disorder
  • Functional Ambulation Category (FAC) score ≥ 2
  • Ability to walk independently prior to stroke

Exclusion Criteria:

  • Severe cognitive or communication impairment
  • Movement limitations due to joint contracture or deformity
  • Presence of open wounds or pressure ulcers
  • Uncontrolled hypertension or orthostatic hypotension
  • Severe cardiovascular disease, heart failure, cancer, or serious pulmonary disease
  • High risk of fracture due to severe osteoporosis
  • Gait impairment caused by lower extremity musculoskeletal disorders
  • Severe psychosis/neurosis
  • Modified Ashworth Scale > 3 in the lower extremities (severe spasticity)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation
Participants will receive 8 sessions of pelvic-free robot-assisted gait training with RoboGait® (2 sessions per week for 4 weeks) in addition to conventional rehabilitation (5 sessions per week for 4 weeks).
Device: RoboGait® Pelvic-Free Mode
Robot-assisted gait training using the RoboGait® system in pelvic-free mode. Participants receive 8 sessions (2 per week for 4 weeks) in addition to conventional rehabilitation.
Other: Conventional Rehabilitation
Standard physiotherapy program consisting of 20 sessions (5 per week for 4 weeks) focused on mobility, strengthening, and functional training. Applied to all participants in both groups.
Active Comparator: Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation
Participants will receive 8 sessions of pelvic-restricted robot-assisted gait training with RoboGait® (2 sessions per week for 4 weeks) in addition to conventional rehabilitation (5 sessions per week for 4 weeks).
Other: Conventional Rehabilitation
Standard physiotherapy program consisting of 20 sessions (5 per week for 4 weeks) focused on mobility, strengthening, and functional training. Applied to all participants in both groups.
Device: RoboGait® Pelvic-Restricted Mode
Robot-assisted gait training using the RoboGait® system in pelvic-restricted mode. Participants receive 8 sessions (2 per week for 4 weeks) in addition to conventional rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
14-item scale assessing static and dynamic balance, scored 0-56 (higher scores indicate better balance).
Baseline (T0) and 4 weeks post-intervention (T1)
Gait Speed
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Gait speed will be assessed using the Zebris FDM-T treadmill system and expressed in meters per second (m/s).
Baseline (T0) and 4 weeks post-intervention (T1)
Step Length
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Step length will be measured with the Zebris FDM-T treadmill system and reported in centimeters (cm).
Baseline (T0) and 4 weeks post-intervention (T1)
Cadence
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Cadence will be recorded using the Zebris FDM-T treadmill system and expressed in steps per minute.
Baseline (T0) and 4 weeks post-intervention (T1)
Double Support Time
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Double support time will be assessed with the Zebris FDM-T treadmill system and expressed as percentage (%) of the gait cycle.
Baseline (T0) and 4 weeks post-intervention (T1)
Temporal Symmetry Index
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Temporal symmetry index will be calculated from gait analysis with the Zebris FDM-T treadmill system and expressed as a percentage (%).
Baseline (T0) and 4 weeks post-intervention (T1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Category (FAC)
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
6-level scale (0-5) evaluating functional walking ability, from non-functional ambulation to independent walking.
Baseline (T0) and 4 weeks post-intervention (T1)
Motricity Index - Lower Limb
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Assesses motor function of the paretic lower limb (score range 0-99)
Baseline (T0) and 4 weeks post-intervention (T1)
Falls Efficacy Scale-International (FES-I)
Time Frame: Baseline (T0) and 4 weeks post-intervention (T1)
Self-reported questionnaire evaluating fear of falling during daily activities (higher scores indicate greater fear).
Baseline (T0) and 4 weeks post-intervention (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meltem Gunes Akinci

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-60116787-020-690593

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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