Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke

NCT05559385 | Completed DMC

• 1 other identifier: 09.2021.168
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR). A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).

Conditions

Stroke

Keywords

Robotic Rehabilitation; Conventional Rehabilitation; Intensıve Trunk Rehabilitation; Motor Function

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Upper Extremity Assessment:

  This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.

  At the baseline

• Fugl-Meyer Upper Extremity Assessment:

  This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition.

  At the end of the 6th week

Secondary Outcomes (5)

• Demographic Data Form

  At the baseline

• - Wolf Motor Function Test:

  At the baseline

• - Wolf Motor Function Test:

  At the end of the 6th week

• Trunk Impairment Scale

  At the baseline

• Trunk Impairment Scale

  At the end of the 6th week

Study Arms (2)

Robotic Rehabilitation Group

EXPERIMENTAL

The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward, and push-ups with a Swiss Ball. This group received a robotic rehabilitation program for the upper extremity with a Houston Bionics ExoRehab X brand/model device. This device has no motor force of repulsion or attraction. Patients initiate and maintain their movements during the exercise. The device supports the patient's active movement and allows extensive movement repetition. Before starting robotic rehabilitation, the patient was seated upright on the platform. The games were projected onto a 43-inch television screen. The exercise program was planned to include upper extremity movements in all directions.

Device: Robot-Assissted Therapy

Conventional Rehabilitation Group

ACTIVE COMPARATOR

The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. During this period, lower extremity rehabilitation was added if needed in addition to trunk rehabilitation. Exercises for the lower extremities were applied according to the patient's individual needs. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward and sideways, and push-ups with a Swiss Ball. CR applied after the ITR program consisted of an individualized rehabilitation program for the upper extremities. These rehabilitation programs generally included activities for functional purposes (dressing, object manipulation, reaching, cup holding, range of motion, strengthening, weight-bearing, etc.). The treatment program was applied five days a week for six weeks, with the session duration limited to 60 minutes.

Procedure: Conventional Rehabilitation

Interventions

Robot-Assissted Therapy DEVICE

Houston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke.

Robotic Rehabilitation Group

Conventional Rehabilitation PROCEDURE

It is an upper extremity rehabilitation program prepared in line with individual needs.

Conventional Rehabilitation Group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-85 years and having had a stroke in the last six months,
• Mini-Mental State Assessment score \>20,
• Able to sit safely,
• No neglect issue,
• Fugl-Meyer Upper Extremity Assessment score \<58.

You may not qualify if:

• Modified Ashworth Scale \>2,
• Severe reduction in visual acuity,
• Participation in another rehabilitation program,
• Subluxation or pain in the shoulder region.

Sponsors & Collaborators

• Emresenocak: lead

Study Sites (1)

Marmara University

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (1)

• Senocak E, Korkut E, Akturk A, Ozer AY. Is the robotic rehabilitation that is added to intensive body rehabilitation effective for maximization of upper extremity motor recovery following a stroke? A randomized controlled study. Neurol Sci. 2023 Aug;44(8):2835-2843. doi: 10.1007/s10072-023-06739-3. Epub 2023 Mar 10.

  PMID: 36897464 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aysel Yildiz Ozer, PhD

  Marmara University

  STUDY DIRECTOR

• Adem Aktürk, PhD

  Gelişim University

  PRINCIPAL INVESTIGATOR

• Elif Korkut, PhD

  Bağcılar Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assisstant

Model Details: A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 29, 2022
• Study Start: January 2, 2022
• Primary Completion: June 17, 2022
• Study Completion: August 5, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

TU (1)