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NCT Number: NCT07365384

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

RoboGait® Pelvic-Free Mode

Device

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.

RoboGait® Pelvic-Restricted Mode

Device

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.

conventional rehabilitation

Other

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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 (%).

Secondary outcomes

  1. 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.

  2. 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)

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Meltem Güneş Akıncı, MD

CONTACT

[email protected]

+902582966000

Sponsors and collaborators

Lead sponsor

Meltem Gunes Akinci

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

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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