Efficacy of a Novel Walking Assist Device With Auxiliary Laser Illuminator on Stroke Patients

NCT03786341 | Completed

• 1 other identifier: VGHKS17-CT8-11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs. Ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke. Walking assist device with auxiliary laser illuminator during ambulation training could correct gait parameters, improve balance and basic activity of daily living among stroke patients.

Conditions

Stroke

Keywords

Gait; Stroke; Walking assist device; Auxiliary illuminator; visual feedback

Outcome Measures

Primary Outcomes (8)

• The change of stride length (meter) of parameters of gait cycle.

  The primary outcome was the stride length (meter) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change of cadence(step/min) of parameters of gait cycle

  The primary outcome was the cadence(step/min) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change of duration of stance phase(%) of parameters of gait cycle

  The primary outcome was the duration of stance phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change of duration of swing phase(%) of parameters of gait cycle

  The primary outcome was the duration of swing phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change of duration of single support (%) of parameters of gait cycle

  The primary outcome was the duration of single support (%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change of double support (%)during the gait cycle

  The primary outcome was the double support (%)during the gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change ofangle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle)

  The primary outcome was the angle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• The change ofangle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle)

  The primary outcome was the angle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

Secondary Outcomes (3)

• The Berg balance scale (BBS)

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• Barthel index (BI)

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

• Timed up and go test (TUG)

  The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

Study Arms (2)

with auxiliary illuminator

EXPERIMENTAL

the walking training was by conventional strategy with lase quad-cane.

Device: with auxiliary illuminator

control group

PLACEBO COMPARATOR

Ambulation training WITHOUT laser quad-cane.

Device: with auxiliary illuminator

Interventions

with auxiliary illuminator DEVICE

Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.

Also known as: control group

control group; with auxiliary illuminator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke patients at subacute (stroke symptoms between three months to one year) or chronic stage (stroke symptoms more than 1 year)
• with hemiplegia
• with sufficient cognition that could follow the instructions and procedure
• walk independently for a distance of more than 20 meters with or without the use of a walking aid.

You may not qualify if:

• Stroke patients with other neurological diseases like Parkinsonism,
• Myopathy
• Multiple sclerosis
• Spinal cord injury that might interfere with walking ability

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital ,

Kaohsiung City, 81362, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pei-Te Hsu, MD.

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients who fulfilled the inclusion and exclusion criteria were randomized (1:1) into two groups, using sequentially numbered, opaque, sealed envelopes (SNOSE) method containing a group assignment number by a person who was not clinically involved in and, therefore, was blinded to this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physical Medicine and Rehabilitation

Model Details: This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: December 26, 2018
• Study Start: December 1, 2017
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)