Effectiveness Analysis of Armeo Spring Device as a Rehabilitation Treatment in Spinal Cord Injured Patients

NCT04383873 | Completed

• 1 other identifier: C501/2016
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Loss of motor function is a consequence after a spinal cord injury (SCI). The incidence of SCI varies greatly from 12.1 to 57.8 cases per million depending on the country. More than 50% of people with SCI have impaired upper limb (UL) function, experiencing limitations in performing functional tasks. In this context, one of the rehabilitation objectives is to achieve the maximum level of independence in the patient in the performance of activities of daily living (ADL). Within the clinical setting, the main motivation in the use of robotic devices and/or exoskeletons for a rehabilitation purpose focuses on the fact that these help therapists in administering repetitive manual therapies to patients during exercises. There is evidence that the amount of therapy patients receive is insufficient. Without creating additional time demands on clinicians, robotic devices can perform the repetitive mechanical aspects of therapy, increasing the amount of therapy that patients receive. However, the current evidence in stroke patients suggests that the improvements observed are due to the intensity of the therapy, regardless of whether the administration of rehabilitation is due to robotic devices and/or traditional means. The main objective of this study is to analyze the effectiveness of the commercial Armeo® Spring system (Hocoma AG, Switzerland) and a Virtual Reality application to repeatedly work the ADL from drinking from a glass, in people with cervical SCI. The ADL of drinking has been chosen, as a representative activity of those related to food, which requires control, strength and coordination of the UL. The study is carried out at the Hospital Nacional de Parapléjicos with the collaboration of Occupational Therapy Unit, the Rehabilitation Department, and the Biomechanics and Technical Aids Unit. This effectiveness is measured in terms of functional improvements and in the quality of the UL movements performed.

Conditions

Spinal Cord Injury Cervical

Keywords

Effectiveness; Rehabilitation; Upper extremity; Spinal Cord Injury cervical; Robotic device

Outcome Measures

Primary Outcomes (13)

• Clinical scale SCIM

  The Spinal Cord Independence Measure (SCIM) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessments of patients with paraplegia or tetraplegia more sensitive to changes. Exclusively designed for spinal injury. It consists of 3 subscales. The total score varies from 0-100 points, where 0 corresponds to the highest degree of dependency and 100 to the highest degree of independence.

  At baseline

• Change from baseline Clinical scale SCIM at 10 weeks

  The Spinal Cord Independence Measure (SCIM) is a new disability scale developed specifically for patients with spinal cord lesions in order to make the functional assessments of patients with paraplegia or tetraplegia more sensitive to changes. Exclusively designed for spinal injury. It consists of 3 subscales. The total score varies from 0-100 points, where 0 corresponds to the highest degree of dependency and 100 to the highest degree of independence.

  At the end of the study (at week 10)

• Clinical scale CUE

  Capabilities of Upper Extremity (CUE) measures upper extremity functional limitations in individuals with tetraplegia. The patient reports the outcome about how well you are able to use the arms and hands of patients. 32 item questionnaire with items in 7 domains. Self-reported measure performed by interview. Score on 7 points scale representing self-perceived difficulty: 1 (Totally limited, can´t do at all) y 7 (Not at all limited). So, the minimum score is 32 (worse result) and the maximum score 224 (greater function)

  At baseline

• Change from baseline Clinical scale CUE at 10 weeks

  Capabilities of Upper Extremity (CUE) measures upper extremity functional limitations in individuals with tetraplegia. The patient reports the outcome about how well you are able to use the arms and hands of patients. 32 item questionnaire with items in 7 domains. Self-reported measure performed by interview. Score on 7 points scale representing self-perceived difficulty: 1 (Totally limited, can´t do at all) y 7 (Not at all limited). So, the minimum score is 32 (worse result) and the maximum score 224 (greater function)

  At the end of the study (at week 10)

• Clinical Scale Jebsen-Taylor Hand Function (JTHF)

  The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities which are timed: writing (copying) a 24-letter sentence turning over a 3 × 5" cards, picking up small common objects such as a coin and bottle cap, simulated feeding using a teaspoon and five kidney beans, stacking checkers picking up large light objects such as an empty tin can, and picking up and moving large weighted cans. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.

  At baseline

• Change from baseline Clinical Scale Jebsen-Taylor Hand Function (JTHF) at 10 weeks

  The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities which are timed: writing (copying) a 24-letter sentence turning over a 3 × 5" cards, picking up small common objects such as a coin and bottle cap, simulated feeding using a teaspoon and five kidney beans, stacking checkers picking up large light objects such as an empty tin can, and picking up and moving large weighted cans. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.

  At the end of the study (at week 10)

• Clinical scale Nine Hole Peg Test

  The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.

  At baseline

• Change from baseline Clinical scale Nine Hole Peg Test at 10 weeks

  The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The scale measures the time in seconds in reaching each task. A higher spent time is a worse outcome.

  At the end of the study (at week 10)

• Clinical Scale GRASSP

  The GRASSP is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains, important in describing arm and hand function: Strength, Sensation, Prehension. The minimal score is 0 (worse outcome) and the maximum 98 (better outcome) for each hand.

  At baseline

• Change from baseline Clinical Scale GRASSP at 10 weeks

  The GRASSP is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains, important in describing arm and hand function: Strength, Sensation, Prehension. The minimal score is 0 (worse outcome) and the maximum 98 (better outcome) for each hand.

  At the end of the study (at week 10)

• Edinburg Handedness Test

  Most people are right handed. The Edinburgh Handedness Inventory is a well known short questionnaire for determining objectively whether one is left or right handed and there is a short form of it. 10 items are valued. The total score is 50 points and the minimum 10 points. The closer score to 50 points, more left-handed the person is. And the closer score to 10 the more right-handed.

  At baseline

• Kinematic indices

  This assessment is performed by means of photogrammetry. Markers are placed on the trunk and the arm analyzed, and kinematic variables about the UL movement are computed in terms of accuracy, agility, coordination, efficiency and smoothness. A score of 100 in each index corresponds to the healthy pattern. The minimun and worse outcome is 0 score.

  At baseline

• Change from baseline Kinematic indices at 10 weeks

  This assessment is performed by means of photogrammetry. Markers are placed on the trunk and the arm analyzed, and kinematic variables about the UL movement are computed in terms of accuracy, agility, coordination, efficiency and smoothness. A score of 100 in each index corresponds to the healthy pattern. The minimun and worse outcome is 0 score.

  At the end of the study (at week 10)

Secondary Outcomes (8)

• Compliance

  At the end of the study (at week 10)

• QUEST usability scale

  At the end of the study (at week 10)

• TMS assessment

  At baseline

• Change from baseline TMS assessment at 10 weeks

  At the end of the study (at week 10)

• Beck's Depression Inventory

  At baseline

Study Arms (2)

Intervention

EXPERIMENTAL

17 cervical Spinal Cord injured patients daily receive 1 hour of upper extremity therapy

Device: Training by means of Armeo Spring device; Other: Current treatment based on conventional therapy

Control

ACTIVE COMPARATOR

17 cervical Spinal Cord injured patients daily receive 1 hour of upper extremity therapy

Other: Current treatment based on conventional therapy; Other: Additional treatment based on conventional therapy

Interventions

Training by means of Armeo Spring device DEVICE

This patients group receive 40 experimental sessions. Each session is based on 30 min by using Armeo Spring device.

Intervention

Current treatment based on conventional therapy OTHER

All the patients enrollment in the study receive 30 min of conventional therapy during 40 sessions.

Control; Intervention

Additional treatment based on conventional therapy OTHER

This intevention was added for providing the same amount of therapy than those patients randomly enrolled in the intervention group. So, patients in the control group receive other 30 min of conventional therapy added on current treatment during 40 sessions.

Control

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cervical lesions above C8, incomplete in the motor aspect or complete with zones of partial motor preservation at least C6, classified according to the ASIA scale.
• Traumatic or non-progressive medical etiology.
• Less than 6 months of injury evolution (subacute).
• Age between 16 and 75 years.
• To have reached the seated posture.
• Be informed and consent to participate in the study.

You may not qualify if:

• Unstable orthopaedic injuries such as unconsolidated fractures or with unstable osteosynthesis systems in upper limbs.
• Skin lesions and/or pressure ulcers in the exoskeleton placement area.
• Having joint stiffness and/or severe spasticity.
• Bronchopneumopathy and/or severe heart disease that will require monitoring during exercise.
• Visual problems.
• Cognitive impairment.
• Do not sign the corresponding informed consent.

Sponsors & Collaborators

• Hospital Nacional de Parapléjicos de Toledo: lead

Study Sites (1)

Hospital Nacional de Parapléjicos

Toledo, 45071, Spain

Location

Study Officials

• Ana de los Reyes, PhD

  Hospital Nacional de Parapléjicos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: May 12, 2020
• Study Start: June 18, 2016
• Primary Completion: November 30, 2021
• Study Completion: December 28, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

ES (1)