Back to resultsRobotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
Primary Purpose
Spinal Cord Injury Cervical
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Rehabilitation
Robotic REhabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury Cervical
Eligibility Criteria
Inclusion Criteria:
- Ages between 18-50
- Cervical Level of Spinal Cord Injury
Exclusion Criteria:
- Severe upper extremity contractures in the joints
- Intensive spasticity (Ashworth 3-4)
- Shoulder pain that causes exercise intolerance
Sites / Locations
- Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi
- Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional Rehabilitation
Robotic Rehabilitation + Conventional Rehab
Arm Description
Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.
The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A
Outcomes
Primary Outcome Measures
Functional Independence Measure
Scale Evaluating the Functionality
Spinal Cord Independence Measure III
Scale Evaluating the Functionality and independence
Short Form-36
Scale Evaluation the activities of daily living
Secondary Outcome Measures
Full Information
NCT ID
NCT03239301
First Posted
July 31, 2017
Last Updated
August 1, 2017
Sponsor
Ankara Physical Medicine and Rehabilitation Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03239301
Brief Title
Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
Official Title
Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Physical Medicine and Rehabilitation Education and Research Hospital
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
Study design: Controlled Trial Objective: To evaluate the effectiveness of robotic-assisted training of forearm and hand functions in spinal cord injury patients Setting: Ankara Physical Medicine and Rehabilitation Training and Research Hospital, Turkey Methods: Forty patients were allocated into robotic and control groups. Both groups received conventional rehabilitation program for four weeks. Moreover, robotic group received robotic rehabilitation program tailored to the patient five times a week (each session of 30 min).
Baseline data and post-intervention data was compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury Cervical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Rehabilitation
Arm Type
Active Comparator
Arm Description
Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.
Arm Title
Robotic Rehabilitation + Conventional Rehab
Arm Type
Active Comparator
Arm Description
The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A
Intervention Type
Procedure
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.
Intervention Type
Procedure
Intervention Name(s)
Robotic REhabilitation
Intervention Description
The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. Assistive component of the robotic arm was adjusted in accordance with motor level of each patient. Variety and difficulty of games were chosen according to the ability and functional status of the patients. Variety and difficulty level of the games were modified according to progress of patients by the same physiotherapist.
Primary Outcome Measure Information:
Title
Functional Independence Measure
Description
Scale Evaluating the Functionality
Time Frame
Four weeks
Title
Spinal Cord Independence Measure III
Description
Scale Evaluating the Functionality and independence
Time Frame
Four weeks
Title
Short Form-36
Description
Scale Evaluation the activities of daily living
Time Frame
Four weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages between 18-50
Cervical Level of Spinal Cord Injury
Exclusion Criteria:
Severe upper extremity contractures in the joints
Intensive spasticity (Ashworth 3-4)
Shoulder pain that causes exercise intolerance
Facility Information:
Facility Name
Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
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