Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
2 active sites
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
First Submitted
Initial submission to the registry
July 31, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 4, 2017
CompletedAugust 4, 2017
August 1, 2017
Same day
July 31, 2017
August 1, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Functional Independence Measure
Scale Evaluating the Functionality
Four weeks
Spinal Cord Independence Measure III
Scale Evaluating the Functionality and independence
Four weeks
Short Form-36
Scale Evaluation the activities of daily living
Four weeks
Study Arms (2)
Conventional Rehabilitation
ACTIVE COMPARATORConventional 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.
Robotic Rehabilitation + Conventional Rehab
ACTIVE COMPARATORThe Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A
Interventions
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. 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.
Eligibility Criteria
You may qualify if:
- Ages between 18-50
- Cervical Level of Spinal Cord Injury
You may not qualify if:
- Severe upper extremity contractures in the joints
- Intensive spasticity (Ashworth 3-4)
- Shoulder pain that causes exercise intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi
Ankara, 06100, Turkey (Türkiye)
Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital
Ankara, 06100, Turkey (Türkiye)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Physical and Rehabilitation Medicine Specialist
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 4, 2017
Study Start
August 1, 2017
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 4, 2017
Record last verified: 2017-08