Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

NCT ID: NCT03239301

Last Updated: 2017-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-08-01

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.

Detailed Description

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Conditions

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Spinal Cord Injury Cervical

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Rehabilitation

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.

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type PROCEDURE

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.

Robotic Rehabilitation + Conventional Rehab

The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. A

Group Type ACTIVE_COMPARATOR

Conventional Rehabilitation

Intervention Type PROCEDURE

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.

Robotic REhabilitation

Intervention Type PROCEDURE

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.

Interventions

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Conventional Rehabilitation

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

Robotic REhabilitation

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.

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Timur Ekiz

Medical Doctor, Physical and Rehabilitation Medicine Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1240

Identifier Type: -

Identifier Source: org_study_id

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