Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

Spinal Cord Injury Cervical Clinical Trial

Official title:

Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239301
• Other study ID #: 1240
• Status: Completed
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 1, 2017
• Start date: August 1, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: Ankara Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury Cervical
• Wounds and Injuries

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Fizik Tedavi ve REhabilitasyon Egitim ve Arastirma Hastanesi	Ankara
Turkey	Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independence Measure	Scale Evaluating the Functionality	Four weeks
Primary	Spinal Cord Independence Measure III	Scale Evaluating the Functionality and independence	Four weeks
Primary	Short Form-36	Scale Evaluation the activities of daily living	Four weeks