Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients

Sponsor
Ankara Physical Medicine and Rehabilitation Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03239301
Collaborator
(none)
40
2
2
20

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conventional Rehabilitation
  • Procedure: Robotic REhabilitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Robotic-assisted Upper Extremity Training in Spinal Cord Injury Patients
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.

Active Comparator: Robotic Rehabilitation + Conventional Rehab

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

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Functional Independence Measure [Four weeks]

    Scale Evaluating the Functionality

  2. Spinal Cord Independence Measure III [Four weeks]

    Scale Evaluating the Functionality and independence

  3. Short Form-36 [Four weeks]

    Scale Evaluation the activities of daily living

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Fizik Tedavi ve REhabilitasyon Eğitim ve Araştırma Hastanesi Ankara Turkey 06100
2 Ankara Physical MEdicine and REhabilitation Trainign and Research Hospital Ankara Turkey 06100

Sponsors and Collaborators

  • Ankara Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Timur Ekiz, Medical Doctor, Physical and Rehabilitation Medicine Specialist, Ankara Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT03239301
Other Study ID Numbers:
  • 1240
First Posted:
Aug 4, 2017
Last Update Posted:
Aug 4, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 4, 2017