Improving Propulsion of the Paretic Leg In Chronic Stroke

NCT04650802 | Completed

• 2 other identifiers: 785_LOPES I-PICSR201605453
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke survivors may have a latent, propulsive capacity of the paretic leg, that can be elicited during short, intensive gait training interventions. The aim of this study was therefor to investigate the effect of a five-week gait training on paretic propulsion, propulsion symmetry, gait capacity, and daily-life mobility and physical activity in chronic stroke survivors.

Conditions

Stroke

Keywords

Gait; Rehabilitation; Robotics; Propulsion; Speed; Biomechanics

Outcome Measures

Primary Outcomes (1)

• Change in propulsion symmetry at self-selected gait speed between pre- and post-intervention

  Propulsion symmetry was calculated by dividing the paretic propulsive impulse by the sum of the paretic and non-paretic propulsive impulse

  Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.

Secondary Outcomes (11)

• Change in self-selected gait speed between pre- and post-intervention

  Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.

• Change in trailing limb angle of the paretic leg between pre- and post-intervention

  Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.

• Change in ankle plantarflexion moment of the paretic leg between pre- and post-intervention

  Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.

• Change in performance on the Six-minute walk test between pre- and post-intervention

  Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.

• Change in performance on the Functional gait assessment between pre- and post-intervention

  Assessments are performed five weeks (T0) and one week (T1) before the start of the intervention, and one week (T2) and five weeks (T3) after the end of the five-week intervention period.

Study Arms (1)

Gait training

EXPERIMENTAL

Participants receive five weeks individual robotic gait training in LOPES II, targeting paretic propulsion (60 minutes, two time a week). The robotic gait training is complemented with daily home exercises (15 minutes/day) focusing on increasing strength and practice of learned strategies in daily life.

Device: Gait training

Interventions

Gait training DEVICE

Participants receive five weeks individual robotic gait training in LOPES II, targeting paretic propulsion (60 minutes, two time a week). The robotic gait training is complemented with daily home exercises (15 minutes/day) focusing on increasing strength and practice of learned strategies in daily life.

Gait training

Eligibility Criteria

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

You may qualify if:

• adults (\>18 years of age) with unilateral ischemic or heamorrhagic supratentorial stroke
• at least 6 months post-onset
• impaired propulsion of the paretic leg during walking at a self-selected speed (≥ 8 percent propulsion asymmetry)
• ability to walk 10 meter without support or use of a walking aid (Functional Ambulatory Categories (FAC) 3-5)
• ability to walk for 5 consecutive minutes, with or without the use of a walking aid
• at least 10 degrees passive hip extension and able to stand plantigrade with extended knee

You may not qualify if:

• inability to move the body upward against gravity (calf muscle - Medical Research Council (MRC) scale \< 3)
• severe cognitive problems assessed with Mini-Mental State Examination (MMSE \< 24)
• depressed mood assessed with the Hospital Anxiety and Depression Score (HADS \> 7)
• persistent unilateral visuospatial neglect assessed with the Star Cancellation Test (score \< 44)
• any medical condition interfering with gait
• inability to understand verbal instructions
• inappropriate or unsafe fitting of the robotic gait trainer, due to severe lower limb spasticity (Modified Ashworth Scale (MAS) ≥ 3), severe lower limb contractures, body weight ≥ 140 kg, or skin problems at body sites where the harness or straps were to be fitted

Sponsors & Collaborators

• Sint Maartenskliniek: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574NA, Netherlands

Location

Related Publications (1)

• Alingh JF, Groen BE, Kamphuis JF, Geurts ACH, Weerdesteyn V. Task-specific training for improving propulsion symmetry and gait speed in people in the chronic phase after stroke: a proof-of-concept study. J Neuroeng Rehabil. 2021 Apr 23;18(1):69. doi: 10.1186/s12984-021-00858-8.

  PMID: 33892754 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• ACH Geurts, Prof. dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal intervention study with two consecutive baseline assessments and a five-week follow-up

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 3, 2020
• Study Start: March 4, 2019
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)