Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

Study Overview
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Brief Summary
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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.

Official Title
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Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

Conditions
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Spinal Cord Injury Cervical

Intervention / Treatment
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* Procedure: Conventional Rehabilitation
* Procedure: Robotic REhabilitation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Rehabilitation<br>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. | Procedure: Conventional Rehabilitation<br>* 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.<br>|
| Active Comparator: Robotic Rehabilitation + Conventional Rehab<br>The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A | Procedure: Conventional Rehabilitation<br>* 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.<br>Procedure: Robotic REhabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |