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PHYSICAL THERAPY TECHNIQUESNCT05485727

Robotic Constraint Lokomat Training for Gait Rehabilitation in Patients with Stroke

A study testing The Lokomat® Pro Hocoma USA & Conventional physical therapy and Conventional Physical Therapy in people with PHYSICAL THERAPY TECHNIQUES, run by Umm Al-Qura University at 2 sites in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate the effect of a lokomat training on gait performance in Saudi females with stroke. Design: A-Single blind randomized controlled trial. Methods: 28 females patients with stroke will be enrolled in this thesis (6-12 months after stroke); the patients will be randomly assigned into… Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
PHYSICAL THERAPY TECHNIQUES
What is being tested?
The Lokomat® Pro Hocoma USA & Conventional physical therapy and Conventional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesSaudi Arabia
Study dates
30 Mar 2022to 10 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 28 stroke female patients, age ranged from 40- 65 years, Lower limb mild to moderate spasticity (Modified Ashwarth Scale 1+ to 3), be able to understand all instructions during intervention (Mini-Mental State Examination Score ≥24 points), \& be able to walk 10 m independently or under supervision

Who cannot join

  • cognitive impairment, behavioral disturbance, serious independent chronic disease likely to interfere with the ability to cooperate with the study, major contracture affecting muscles of the leg, Joint pathology of the lower limb other than that directly related to hemiplegia (eg, previous fractures, severe articular blocks); Patients under antispastic drug. Heart failure, unstable angina, uncontrolled hypertension peripheral arteriovenous occlusive disease. Neurogenic condition (other than stroke) affecting the gait pattern (e.g. ataxia, peripheral neuropathy, vertebrobasilar insufficiency and myelopathy), and patients with advanced osteoarthritis, and obesity (BMI > 30)

Trial locations and contacts

2 sites in 1 country.

Saudi Arabia2 sites
  • Faculty of Applied Medical Science - UQU

    Jeddah

  • UQU- KSA

    Jeddah

Other trials in Saudi Arabia

About this study

Official title: Uses of Robotic Constraint Lokomat Training on Gait Rehabilitation in Saudi Females Patients with Stroke- a Randomized Controlled Study

The aim of this study is to investigate the effect of a lokomat training on gait performance in Saudi females with stroke. Design: A-Single blind randomized controlled trial. Methods: 28 females patients with stroke will be enrolled in this thesis (6-12 months after stroke); the patients will be randomly assigned into two equal groups of 14. Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy, while the other group is a control group (CG) will receive conventional physiotherapy. Duration of treatment will be 3 months. The lower limb joint range of motion, Balance, activities of daily living, walk speed, muscle tone of the lower limbs will be recorded before and after treatment and will compared between both groups.

Read the detailed description

Background: Stroke is considered one of the main causes of morbidity and mortality and the contributing cause of disability in human adults. Gait performances were dramatically affected and reduced after stroke. Purpose: The aim of this study is to investigate the effect of a lokomat training on gait performance in stroke patients of Saudi women. Design: A-Single blind randomized controlled trial. Methods: Twenty-eight females of stroke patients will be enrolled in this thesis (6-12 months after stroke); the patients will be randomly assigned into two equal groups of 14. Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy, while the other group is a control group (CG) will receive conventional physiotherapy. Duration of treatment will be of three months. Randomization was performed by random number generator of the Microsoft Office Excel Software. Intervention: Both groups will be evaluated before and after treatment (3-month duration). LokomatPro is designed to improve training efficiency, RG will be compared with conventional manually assisted therapy CG. The device has all the necessary elements to enable effective robotic gait training. On a treadmill, the Lokomat's powered robotic gait orthosis legs lead the subject through walking movements, supporting their body weight(with safe belts) and allowing them to use their legs more freely. Over time, the degree of body weight support and direction will be reduced to more closely resemble typical unsupported walking. The Lokomat is linked to a video game that provides feedback on the amount of force the subject will generate. The motions of the joint's angles and linear motion for lower limb (hip, knee, and ankle excursions) and Lokomat will be recorded when the patients walk on a treadmill and inside the Lokomat. Patients will walk for roughly 30 minutes three times a week for a total of twelve weeks. Instrumentations:3D Motion analysis system, with 10 cameras Bonita Model, connected with 2-force plate (AMTI), and EMG (8Channels), Nexus Version 2.5 (will used for gait analysis before and after use of lokomat). The Lokomat® Pro Hocoma USA (Enhanced Functional Locomotion Therapy with Augmented Performance Feedback) consists of the robotic gait orthosis and an advanced body weight support system, combined with a Treadmill. (used for gait training). Berg's Balance Scale (BBS) to measure balance. Modified Barthel Index (MBI) to measure activities of daily living, respectively, The Rivermead Mobility Index (RMI) will be used to assess the functional mobility of the patients (This 15-item test is a hierarchical mobility scale including rolling in bed to running, a higher score indicates better mobility performance), Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity), Timed-Up and Go test (TUG) will be used to assess balance and functional mobility together, (a lower duration indicates better mobility performance). Outcome measure The lower limb joint range of motion, Balance, and activities of daily living, walk speed, muscle tone of the lower limbs will be recorded before and after treatment and will compared between both groups. Statistical analysis: Data calculated by using the computer package SPSS 8.0. Individual data will be expressed in mean and standard deviation (SD). Un Paired t-test will used to compare between the results of the same group before and after treatment. Paired t-test will used to compare between the results both groups after treatment with level of significance at P≤ 0.05.

Being tested
The Lokomat® Pro Hocoma USA & Conventional physical therapy, Conventional Physical Therapy
Keywords
Stroke, Gait, Balance, Lokomat.
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Lokomat® Pro Hocoma USA & Conventional physical therapyOther

    Also called Robotic Constraint Lokomat Training, (Enhanced Functional Locomotion Therapy with Augmented Performance Feedback)

    Lokomat Consists of robotic gait orthosis and an advanced body weight support system, combined with a Treadmill. (used for gait training) and Conventional Physical Therapy

  • Conventional Physical TherapyOther

    Also called Designed Program of physical therapy rehabilitation for stroke patients for lower limbs

    Balance Exercises , Gait training, Trunk control, Range of motion exercises for lower limbs

Study groups in NCT05485727
Study groupRoleWhat they receive
RG(Robotic group= study group)Experimental14, Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy
Receives: Other: The Lokomat® Pro Hocoma USA & Conventional physical therapy; Other: Conventional Physical Therapy
& CG( Control group)Active comparatorcontrol group (CG) will only receive conventional physiotherapy
Receives: Other: Conventional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. lower limb joint range of motion

    3D Motion analysis system, with 10 cameras Bonita Model, connected with 2-force plate (AMTI), and EMG (8Channels), Nexus Version 2.5 (will used for gait analysis before and after lokomat usage)

    Measured: 3 months

  2. Balance

    Berg's Balance Scale (BBS) to measure balance

    Measured: 3 months

  3. Activities of daily living

    Modified Barthel Index (MBI) to measure activities of daily living

    Measured: 3 months

  4. Spasticity of the lower limbs

    Modified Ashowrth Scale (MAS) For muscle tone assessment (Spasticity

    Measured: 3 months

  5. Gait speed

    Timed-Up and Go test (TUG) will be used to assess gait speed with dynamic balance

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start30 Mar 2022
  3. Primary completion30 Sep 2023
  4. Study completion10 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
stroke patients(28) will be enrolled in this thesis (6-12 months after stroke); the Patients will be randomly assigned into two equal groups of 14. Robotic-assisted gait training group (RG) will receive Lokomat gait training and conventional physiotherapy, while the other group is a control group (CG) will receive conventional physiotherapy.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485727
Sponsor's protocol ID
(HAPO-02-K-012-2022-03-1024)
Status last verified
Aug 2022
First submitted
1 Aug 2022
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Results , Methodology , Publication

Publications

  • Mahmoud H, El-Kafy EA, Alayat MS, Shalabi KM, Ebid AA, El Fiky AAR. The Effectiveness of Robotic Constraint Lokomat Training on Gait Rehabilitation in Saudi Females Patients with Stroke: A Randomized Controlled Trial. NeuroRehabilitation. 2025 Aug;57(1):70-79. doi: 10.1177/10538135251333349. Epub 2025 May 11.

    PubMed 40350663

Questions about this trial

What is this clinical trial studying?

A study testing The Lokomat® Pro Hocoma USA & Conventional physical therapy and Conventional Physical Therapy in people with PHYSICAL THERAPY TECHNIQUES, run by Umm Al-Qura University at 2 sites in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lower limb joint range of motion (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05485727, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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