Feasibility and to explore the effect of biofeedback gait training on the GRAIL in clubfoot patients, over 4 years of age, with a mild relapse

Feasibility and to explore the effect of biofeedback gait training on the GRAIL in clubfoot patients, over 4 years of age, with a mild relapse - Biofeedback gait training in clubfoot patients (GAITIC)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57166

Enrollment

Registered

2024-09-09

Start date

2025-02-14

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clubfoot

Interventions

6 weeks of GRAIL training through games at the Center for Rehabilitation of the University Medical Center Groningen. We will use both longer existing games used in usual care gait training and a gam

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Patients with idiopathic clubfeet treated by Ponseti Method with a diagnosis of recurrence over 4 years of age. Can follow instructions for the biofeedback training and are able to follow the training 2 to 3 times a week for a period of 6 weeks.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Patients younger than 4 years of age, suffering fixed joint contractures in the sub-talar or talocrural joints, severe strength deficits in the ankle evertor muscles (

Design outcomes

Primary

Measure	Time frame
Feasibility expressed as the percentage of completed training sessions	—

Secondary

Measure	Time frame
Feasibility other: General training time, expressed as total amount of minutes training on the grail Specific training time, expressed as the total amount of minutes of specific training (balance, eversion etc.) Training intensity, expressed as level of difficulty that a child reaches during the training (task complexity, walking speed, etc) Experience of the training by the children, parents and grail physiotherapist Percentage of patients that join the study as part of all patients that are asked to join the study Effectiveness; Effectiveness expressed as improvement in peak foot progression Maximum voluntary ankle evertor muscle strength based on a physical assessment using the medical research council scale (MRC scale). Ankle in-eversion joint angle and peak foot progression after 3 weeks of training measured with data of real time ankle foot position during walking on the grail and after six weeks and three months measured with gait analysis, at the gait analysis laboratory Gait analysis after six weeks of training on 1. Active and passive range of motion ankle, knee and hip 2. MRC muscle strength inversion, eversion, dorsiflexion ankle 3. EMG Muscle activity 4. Unilateral heel rise 5. Foot progression angle 6. Ground reaction force 7. Dynamic knee hyperextension 8. Dropfoot in swing 9. Dynamic forefoot supination 10. Equinus in stance 11. Midfoot break 12. Initial contact 13 Early heel lift, compared to pre training gait analysis. Gait analysis data 3 months after stop of the training on 1. Active and passive range of motion ankle, knee and hip 2. MRC muscle strength inversion, eversion, dorsiflexion ankle 3. EMG Muscle activity 4. Unilateral heelrise 5. Foot progression angle 6. Ground reaction force 7. Dynamic knee hyperextension 8. Drop foot in swing 9. Dynamic forefoot supination 10. Equinus in stance 11. Midfoot break 12. Initial contact 13. Early heel lift, compared to pre training gait analysis.	—

Measure

Time frame

Feasibility other: General training time, expressed as total amount of minutes training on the grail Specific training time, expressed as the total amount of minutes of specific training (balance, eversion etc.) Training intensity, expressed as level of difficulty that a child reaches during the training (task complexity, walking speed, etc) Experience of the training by the children, parents and grail physiotherapist Percentage of patients that join the study as part of all patients that are asked to join the study Effectiveness; Effectiveness expressed as improvement in peak foot progression Maximum voluntary ankle evertor muscle strength based on a physical assessment using the medical research council scale (MRC scale). Ankle in-eversion joint angle and peak foot progression after 3 weeks of training measured with data of real time ankle foot position during walking on the grail and after six weeks and three months measured with gait analysis, at the gait analysis laboratory Gait analysis after six weeks of training on 1. Active and passive range of motion ankle, knee and hip 2. MRC muscle strength inversion, eversion, dorsiflexion ankle 3. EMG Muscle activity 4. Unilateral heel rise 5. Foot progression angle 6. Ground reaction force 7. Dynamic knee hyperextension 8. Dropfoot in swing 9. Dynamic forefoot supination 10. Equinus in stance 11. Midfoot break 12. Initial contact 13 Early heel lift, compared to pre training gait analysis. Gait analysis data 3 months after stop of the training on 1. Active and passive range of motion ankle, knee and hip 2. MRC muscle strength inversion, eversion, dorsiflexion ankle 3. EMG Muscle activity 4. Unilateral heelrise 5. Foot progression angle 6. Ground reaction force 7. Dynamic knee hyperextension 8. Drop foot in swing 9. Dynamic forefoot supination 10. Equinus in stance 11. Midfoot break 12. Initial contact 13. Early heel lift, compared to pre training gait analysis.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026