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The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury

Primary Purpose

Tetraplegia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Robot Assisted Therapy
Conventional Therapy
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tetraplegia focused on measuring Tetraplegia, Spinal cord injury, Robotic assisted therapy, Hand rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Mini mental test score >15 Able to understand the commands Had a function between 1 and 4 in at least one of the key muscle strengths in at least one hand. Exclusion Criteria: Patients with persistent pain in the upper extremity (VAS>40) Patients with severe spasticity in the hand (MAS≥3) Patients with severe limitation of joint range of motion / contracture in the hand Patients who had fractures or operations in the upper extremity in the last 6 months Patients who received botulinum toxin injection to the upper extremity in the last 6 months Patients with skin ulcers Patients with severe visual impairment and severe depression Patients who cannot sit in a chair for more than 30 minutes Patients with a history of stroke or progressive neurodegenerative disease Patients with neuromuscular disease Patients with uncontrolled epilepsy

Sites / Locations

  • Sevda Adar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot Assisted Therapy Group

Conventional Therapy Group

Arm Description

In the RAT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes for both upper extremities, accompanied by a physiotherapist who is trained in robotic rehabilitation and has at least 5 years of experience. In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.

In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.

Outcomes

Primary Outcome Measures

American spinal cord injury association impairment scale
The ASIA Evaluation determines the level of injury in patients with spinal cord injury (SCI) based on the levels of sensory, motor, and neurologic injury. Neurological injury level (NLI): NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided there is normal (integrated) sensory and motor function rostrally.
Sollerman hand function test
It consists of 20 different activities based on eight basic hand grips (pulp grip, lateral pinch, triple pinch, 5-finger pinch, diagonal volar grip, transverse volar grip, spherical volar grip, extension type grip). It also evaluates functional properties. Scoring of activities was done in the range of 0-4, according to the completion time of the activity. Failure to perform the activity 0, if it is performed in 60 seconds 1, if it is completed between 60-41 seconds or not with the desired grip pattern 2, if it is completed between 21-40 seconds and there is a minimum deviation in the grip pattern 3, if it is completed within 20 seconds with the specified grip pattern 4 points evaluated.The scoring rules were chosen so that subjects with normal hand function would achieve 80 points. As the score increases, the success rate of the test increases.
Nine Hole Peg Test
This test measures dexterity based on performance (in seconds). A wooden board with nine holes on it, 9 short wooden sticks and a box in which the wooden sticks can be placed are placed in front of the patient. Using the hand to be evaluated, the patient is asked to place the wooden sticks in the box into the holes on the panel as quickly as possible. Then, he is asked to put the sticks back into the box one by one. The completion time of the test is determined by a stopwatch. In this test, which evaluates manual dexterity based on performance, the success rate increases as the time gets shorter.
Box and block test
It is used to evaluate rough manual dexterity based on performance (time). 150 small wooden cubes are filled from the box with the patient's hand to be tested into the adjacent box. The patient is asked to throw one cube at a time into the semi-empty box. How many cubes are thrown in 60 seconds is counted. The result gives the score. How many cubes are thrown in 60 seconds is counted. The result gives the score. The higher the score, the higher the success rate.
Jamar pinchmeter
The hand grip strength of the participants will be measured with the 'Jamar Hand Dynamometer'. Measurements will be made with the shoulder adjacent to the trunk in adduction and neutral rotation, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumbs up. In the dominant and non-dominant hands, the measurements will be repeated three times (first right, then left and again right, etc.) with an interval of 5 seconds, and the average of the three measurements will be recorded in kilograms. The higher the score, the higher the success rate.
Jamar hand dynamometer
Finger grip strength will be evaluated with a 'Jamar digital pinchmeter'. Patients will be placed in a sitting position with the wrist in 90° flexion and the forearm in a neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg.The higher the score, the higher the success rate

Secondary Outcome Measures

Spinal cord injury independence scale
It is a test that determines the functional status in spinal cord injury. It is evaluated between 0-100 points. It consists of 17 items in total. This scale consists of self-care, respiratory-sphincter control and mobility subsections. : It is evaluated between 0-100 points. The higher the score, the higher the success rate.
Modified Ashworth Scale
In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.
Functional Independence Scale
It is a scale that evaluates the performance of individuals regarding activities of daily living. It consists of 18 items and evaluates the functions of individuals in 2 main sections: physical/motor function (13 items) and cognitive function (5 items). The items also include 6 subheadings (self-care, sphincter control,transfers, movement, communication, and social-perception).Each item is scored between 1-7; 1 indicates full assistance and 7 indicates complete independence. The total score ranges between 18-126 (fully dependent-fully independent).
Short form 36
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100 Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.Total score was between 0 ( disability) and 100 (no disability).

Full Information

First Posted
January 31, 2023
Last Updated
July 19, 2023
Sponsor
Afyonkarahisar Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05726773
Brief Title
The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury
Official Title
The Effect of Robot Assisted Hand Therapy on Hand Functions and Quality of Life in Patients With Spinal Cord Injury: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. In this study, our aim is to compare the effects of robot-assisted hand therapy and conventional physiotherapy on hand functions and quality of life in patients with spinal cord injury.
Detailed Description
Spinal cord injury (SCI) is considered one of the most devastating injuries that cause lifelong disability.Among the impaired functions, upper extremity function is one of the most important goals of rehabilitation for these individuals.Hand functions are among the most important determinants of independence.Some studies have reported that in more than half of people with tetraplegia, restoring arm and hand function will improve quality of life.Therefore, small improvements in upper extremity function can make a clinically significant difference in feeding, bathing, transferring and other functional activities.Given that the majority of individuals with spinal cord injuries are in their most productive years and life expectancy approaches that of the healthy population, more aggressive treatment strategies that focus on improving peripheral muscle control and recovery of the central nervous system (CNS) are needed.Recently, treatment based on the 'motor learning theory' has been reported to be effective in the recovery of impaired upper extremity function.It has been shown that by repetitive movements as intense as possible to help achieve the ultimate goal of optimum movement, patients are able to learn motor skills that lead to CNS recovery.It has also been suggested that repetitive and activity-based exercise may facilitate recovery after spinal cord injury by inducing practice-dependent brain and spinal cord plasticity.Therefore, repetitive, intensive, and activity-based upper extremity rehabilitative therapy can help improve impaired upper extremity function.In this context, robotic therapy (RT) may be an alternative way of delivering rehabilitative therapy to patients with tetraplegia, as RT can deliver consistently high-intensity, high-repetition, and task-specific training with less effort compared to conventional therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetraplegia
Keywords
Tetraplegia, Spinal cord injury, Robotic assisted therapy, Hand rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot Assisted Therapy Group
Arm Type
Experimental
Arm Description
In the RAT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes for both upper extremities, accompanied by a physiotherapist who is trained in robotic rehabilitation and has at least 5 years of experience. In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.
Arm Title
Conventional Therapy Group
Arm Type
Active Comparator
Arm Description
In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.
Intervention Type
Procedure
Intervention Name(s)
Robot Assisted Therapy
Intervention Description
In robotic rehabilitation, continuous passive range of motion (CPM), active assistive exercises and assistive continuous passive range of motion (CPM Plus) programs will be used.
Intervention Type
Procedure
Intervention Name(s)
Conventional Therapy
Intervention Description
In the Conventional Therapy group, an exercise program consisting of passive and active assistive range of motion exercises, strengthening exercises and task-oriented exercises for 30 minutes for both hands was planned, accompanied by a physiotherapist experienced in spinal cord injury rehabilitation for at least 5 years.
Primary Outcome Measure Information:
Title
American spinal cord injury association impairment scale
Description
The ASIA Evaluation determines the level of injury in patients with spinal cord injury (SCI) based on the levels of sensory, motor, and neurologic injury. Neurological injury level (NLI): NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided there is normal (integrated) sensory and motor function rostrally.
Time Frame
15 minutes
Title
Sollerman hand function test
Description
It consists of 20 different activities based on eight basic hand grips (pulp grip, lateral pinch, triple pinch, 5-finger pinch, diagonal volar grip, transverse volar grip, spherical volar grip, extension type grip). It also evaluates functional properties. Scoring of activities was done in the range of 0-4, according to the completion time of the activity. Failure to perform the activity 0, if it is performed in 60 seconds 1, if it is completed between 60-41 seconds or not with the desired grip pattern 2, if it is completed between 21-40 seconds and there is a minimum deviation in the grip pattern 3, if it is completed within 20 seconds with the specified grip pattern 4 points evaluated.The scoring rules were chosen so that subjects with normal hand function would achieve 80 points. As the score increases, the success rate of the test increases.
Time Frame
60 minutes
Title
Nine Hole Peg Test
Description
This test measures dexterity based on performance (in seconds). A wooden board with nine holes on it, 9 short wooden sticks and a box in which the wooden sticks can be placed are placed in front of the patient. Using the hand to be evaluated, the patient is asked to place the wooden sticks in the box into the holes on the panel as quickly as possible. Then, he is asked to put the sticks back into the box one by one. The completion time of the test is determined by a stopwatch. In this test, which evaluates manual dexterity based on performance, the success rate increases as the time gets shorter.
Time Frame
20 minutes
Title
Box and block test
Description
It is used to evaluate rough manual dexterity based on performance (time). 150 small wooden cubes are filled from the box with the patient's hand to be tested into the adjacent box. The patient is asked to throw one cube at a time into the semi-empty box. How many cubes are thrown in 60 seconds is counted. The result gives the score. How many cubes are thrown in 60 seconds is counted. The result gives the score. The higher the score, the higher the success rate.
Time Frame
30 minutes
Title
Jamar pinchmeter
Description
The hand grip strength of the participants will be measured with the 'Jamar Hand Dynamometer'. Measurements will be made with the shoulder adjacent to the trunk in adduction and neutral rotation, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumbs up. In the dominant and non-dominant hands, the measurements will be repeated three times (first right, then left and again right, etc.) with an interval of 5 seconds, and the average of the three measurements will be recorded in kilograms. The higher the score, the higher the success rate.
Time Frame
5 minutes
Title
Jamar hand dynamometer
Description
Finger grip strength will be evaluated with a 'Jamar digital pinchmeter'. Patients will be placed in a sitting position with the wrist in 90° flexion and the forearm in a neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg.The higher the score, the higher the success rate
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Spinal cord injury independence scale
Description
It is a test that determines the functional status in spinal cord injury. It is evaluated between 0-100 points. It consists of 17 items in total. This scale consists of self-care, respiratory-sphincter control and mobility subsections. : It is evaluated between 0-100 points. The higher the score, the higher the success rate.
Time Frame
15 minutes
Title
Modified Ashworth Scale
Description
In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.
Time Frame
10 minutes
Title
Functional Independence Scale
Description
It is a scale that evaluates the performance of individuals regarding activities of daily living. It consists of 18 items and evaluates the functions of individuals in 2 main sections: physical/motor function (13 items) and cognitive function (5 items). The items also include 6 subheadings (self-care, sphincter control,transfers, movement, communication, and social-perception).Each item is scored between 1-7; 1 indicates full assistance and 7 indicates complete independence. The total score ranges between 18-126 (fully dependent-fully independent).
Time Frame
15 minutes
Title
Short form 36
Description
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100 Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.Total score was between 0 ( disability) and 100 (no disability).
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Mini mental test score >15 Able to understand the commands Had a function between 1 and 4 in at least one of the key muscle strengths in at least one hand. Exclusion Criteria: Patients with persistent pain in the upper extremity (VAS>40) Patients with severe spasticity in the hand (MAS≥3) Patients with severe limitation of joint range of motion / contracture in the hand Patients who had fractures or operations in the upper extremity in the last 6 months Patients who received botulinum toxin injection to the upper extremity in the last 6 months Patients with skin ulcers Patients with severe visual impairment and severe depression Patients who cannot sit in a chair for more than 30 minutes Patients with a history of stroke or progressive neurodegenerative disease Patients with neuromuscular disease Patients with uncontrolled epilepsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SEVDA ADAR
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sevda Adar
City
Afyonkarahisar
ZIP/Postal Code
5325940725
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury

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