NCT05726773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

January 31, 2023

Last Update Submit

July 19, 2023

Conditions

Tetraplegia

Keywords

TetraplegiaSpinal cord injuryRobotic assisted therapyHand rehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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.

    15 minutes

  • 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.

    60 minutes

  • 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.

    20 minutes

  • 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.

    30 minutes

  • 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.

    5 minutes

  • 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

    5 minutes

Secondary Outcomes (4)

  • Spinal cord injury independence scale

    15 minutes

  • Modified Ashworth Scale

    10 minutes

  • Functional Independence Scale

    15 minutes

  • Short form 36

    15 minutes

Study Arms (2)

Robot Assisted Therapy Group

EXPERIMENTAL

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.

Procedure: Robot Assisted TherapyProcedure: Conventional Therapy

Conventional Therapy Group

ACTIVE COMPARATOR

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.

Procedure: Conventional Therapy

Interventions

Robot Assisted TherapyPROCEDURE

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.

Robot Assisted Therapy Group
Conventional TherapyPROCEDURE

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.

Conventional Therapy GroupRobot Assisted Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevda Adar

Afyonkarahisar, 5325940725, Turkey (Türkiye)

Location

MeSH Terms

Conditions

QuadriplegiaSpinal Cord Injuries

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • SEVDA ADAR

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 14, 2023

Study Start

December 15, 2021

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)