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

NCT07365384 | Not Yet Recruiting

• 1 other identifier: E-60116787-020-690593
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stroke; Hemiplegia; Gait Disorder, Sensorimotor; Balance Impairment; Fear of Falling

Outcome Measures

Primary Outcomes (6)

• Berg Balance Scale

  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

  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

  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

  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

  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

  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 Outcomes (3)

• Functional Ambulation Category (FAC)

  Baseline (T0) and 4 weeks post-intervention (T1)

• Motricity Index - Lower Limb

  Baseline (T0) and 4 weeks post-intervention (T1)

• Falls Efficacy Scale-International (FES-I)

  Baseline (T0) and 4 weeks post-intervention (T1)

Study Arms (2)

Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation

EXPERIMENTAL

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; Other: Conventional Rehabilitation

Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation

ACTIVE COMPARATOR

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).

Device: RoboGait® Pelvic-Restricted Mode; Other: Conventional Rehabilitation

Interventions

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.

Pelvic-Free Robot-Assisted Gait Training + 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.

Pelvic-Restricted Robot-Assisted Gait Training + 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.

Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation; Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Meltem Gunes Akinci: lead

Related Publications (3)

• Lee J, Chun MH, Seo YJ, Lee A, Choi J, Son C. Effects of a lower limb rehabilitation robot with various training modes in patients with stroke: A randomized controlled trial. Medicine (Baltimore). 2022 Nov 4;101(44):e31590. doi: 10.1097/MD.0000000000031590.

  PMID: 36343085 RESULT

• Aurich-Schuler T, Gut A, Labruyere R. The FreeD module for the Lokomat facilitates a physiological movement pattern in healthy people - a proof of concept study. J Neuroeng Rehabil. 2019 Feb 6;16(1):26. doi: 10.1186/s12984-019-0496-x.

  PMID: 30728040 RESULT

• Alingh JF, Weerdesteyn V, Nienhuis B, van Asseldonk EHF, Geurts ACH, Groen BE. Immediate after-effects of robot-assisted gait with pelvic support or pelvic constraint on overground walking in healthy subjects. J Neuroeng Rehabil. 2019 Mar 15;16(1):40. doi: 10.1186/s12984-019-0506-z.

  PMID: 30876445 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Meltem Güneş Akıncı, MD

CONTACT

+902582966000; mgakinci@pau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation, Pamukkale University

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: January 26, 2026
• Study Start: January 15, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share